Surgical Technique

Genutech ® CCK total knee revision system

Table of contents

SURGICAL TECHNIQUE
1. TIBIAL TIME (I) 2
1.1 Intramedullary fixation 2
1.2 Assembly and fitting of the tibial cutting guide 4
1.3 Tibial resection 7
1.4 Measuring of the tibial tray 8
1.5 Measuring of the interline 9
2. FEMORAL TIME 10
2.1 Measuring of the femoral component 10
2.2 Intramedullary fixation 11
2.3 Distal cut 14
2.4 Femoral cuts 15
2.5 Verification of stability during flexo-extension 20
2.6 Reaming to house the femoral post 21
2.7 Assembly of the trial femoral component 23
3. TIBIAL TIME (II) 24
4. MOBILITY / STABILITY CHECK 29
5. PATELLA TIME 30
6. FINAL IMPLANT 31
ANNEXES 32
IMPLANTS AND INSTRUMENTS 44
 Surgical Technique

1. TIBIAL TIME (I) Set 0. Upper tray

1.1 Intramedullary fixation

Diaphyseal intramedullary reaming

To ensure good stability on the diaphyseal axis of the reamer, which serves as a guide and support during surgery, intramedullary reaming is performed,
with a depth according to the length of the stem which is going to be used.

Diameter of the reaming: The recommended diameters for this reaming are normally around Ø9-10 or 11mm, although the suitability of the final
diameter for the tibial diaphysis to be used is always at the discretion of the surgeon and, through gradual reaming, it may even be close to that
of the inner cortex diameter fitting. This is the case when a 200 mm stem must be inserted.

Depth: Generally, the diaphyseal reamer is inserted up to the second 70-120-200 mark, because at this depth greater stability, accuracy, tighte-
ning and safety are achieved for the installation of the tibial cutting guide. If it is not possible to penetrate this deeply (short tibia, fracture callus
which closes the medullary cavity…), at a minimum it must penetrate as far as the 70 mark in order to house a stem which is 70 mm long.

The diameter and depth are marked on the axis of the diaphyseal reamer, and as the tibial time is being performed, depths must be adjusted according
to the marks close to the initial T, depending on the length of the tibial stem (70, 120 or 200 mm) which you intend to implant.

2
 Set 0. Lower tray

Intramedullary reaming guided by cannulated reamers

During this step use the stem of the diaphyseal reamer as a guide.

Depth: In order to install the 70 mm stem, ream until the first 70 mark is level with the tibia surface and if, on the other hand, the stem must be
102 or 200 mm, ream until the second 120-200 mark.

Diameter: Carry out gradual reaming in order to carve the cavity which will house the tibial stem.

Cavity reamed
to house
tibial stem

Note:
When using a 200 m stem, the diameters of the reamers (diaphyseal and cannulated) will be the same, because in order to reach a reaming depth of
200 mm, you use part of the length of the reaming which has already been completed to secure the diaphyseal reamer.

(See other examples of intramedullary reaming according to the length of the stem being implanted in Annex I)
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 Surgical Technique

Set 0. Lower tray

Insertion of the metaphyseal sleeve
Once the guided cannulated reaming has been completed at the chosen depth, insert a metaphyseal sleeve to ensure that there is the necessary sta-
bility to secure the cutting guides, thus ensuring optimal cutting accuracy and congruency in how the tibial tray is positioned in relation to the stem.

The diameter of the sleeve being used is the same as the diameter of the last cannulated reamer which was used, installing a short metaphyseal sleeve
if the reaming was performed in order to insert a 70 mm stem, or a long one if reaming has reached the second mark (120-200) to insert a 120 or 200
mm stem.

The sleeves must be inserted with the revision sleeve inserter/extractor at a minimum depth, as indicated on the axis of the inserter, according to the
readings which correspond to the surgical time we are performing (tibia or femur) and the type of surgery being carried out (Semi-Constrained Revision
“REV” or Primary Semi-Constrained “PRIM”).

1.2 Assembly and fitting of the tibial cutting guide

Set 0. Upper tray
Assembly of the tibial cutting guide
After performing intramedullary fixation of the reamer with the help of the metaphyseal sleeve, on the protruding stem assemble the telescopic guide
system with the corresponding tibial cutting guide (right or left), distally clamping it to the patient’s ankle with the help of the distal clamp for the
tibial guide.

4
 Graduation for
displacement control
Transverse connector

Fixation
screws
Tibial cutting
guide

Telescopic
guide system
Tibial
Tibial clamp cutting guide

Fitting of the tibial cutting guide

On the tibial cutting guide there is a threaded displacement measuring system, which allows you to have strict control over the steps we take. This
system must be adjusted into position 0 before it is used.
In order to find reference “0”, insert the probe hook into the standard cutting slot (slot “0”) and the whole system travels on the axis of the reamer, until
the tip of it rests on the most prominent area of the tibia.

In this position tighten the blocking screws or fixation screws of the transverse connector and of the telescopic guide, and then install the revision probe.

Transverse connector

Blocking
screws

Slot “0”
Reference “0”

Probe hook

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 Surgical Technique

Set 1. Upper tray

Installation of the revision probe of 0-8 or 0-12 mm

In the most favourable cases, where you only need to make a thin cut to sanitise the tibial
surface, with the “0” end (short arm) of the probe, look for the most depressed area of the
tibial plateau to ensure that the cut being made is always below said point. To do this you
must use the threaded displacement measuring system to move it down until it rests on said
area. Once the most depressed area has been reached, fix the tibial cutting guide and then
make the cut.

In extreme cases, in which the tibia is extremely damaged, a prosthesis has been replaced
with supplements or it is necessary to sanitise a bone which is significantly (8 mm, 12 mm,
etc.). Using supplements, in the medial, lateral or even the bilateral area, proceed as follows:
The ”0” end (short arm of the tibial probe) must be directed towards the most depressed
area of the most prominent tibial plateau. To do this you must use the threaded displacement
measuring system to move it down until it is rests on said area.

Then note down the amount of millimetres which the system has gone down (see measure-
ment on the graduated marks on the telescopic guide).

With the arm of the rod in position “8” or “12” probe the most depressed area of the plateau
with the most wear, and the following situations may arise:

a) The 8 mm arm of the “0-8” probe does not fit

In this case cut to +8 and install an 8 mm tibial supplement below the tibial tray
on that side.

b) The 8 mm arm is not in contact

In this situation, assemble the “0-12” probe, trying to ensure contact with its
12 mm arm, and the following situations may arise:

b1) The 12 mm arm does not fit, leaving two options:

· Move it down with the sheave of the tibial cutting guide until the 8 mm arm
touches the area with the most wear, making a +8 mm recut in that area. In this
situation there will be additional displacement with the sheave to transfer it to
the thickness of the tibial insert (to maintain the interline), and an 8 mm tibial
supplement will be used in the aforementioned most depressed area.
· Keep the cutting guide in its initial position and recut +12 on the plateau with
most wear, using a 12 mm tibial supplement.

b2) The 12 mm arm is not in contact

Move down the threaded displacement measuring system to the 12 mm arm, ma-
king a +12 recut in the most depressed area to use a 12 mm tibial supplement.
You must also take into account the amount of millimetres which the cutting guide
has moved downwards with the threaded displacement system and add them to
the thickness of the tibial insert and ensure that the interline is maintained. Note:
Move the system down until the probe touches the ti-
bial plateau.
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PRIMARY TIBIAL SURGERY Set 1. Upper tray

When performing primary tibial surgery by implanting a semi-constrained prosthesis tibial component, install the “0-10” rod on the tibial cutting guide.

Firstly, the “10” end of the probe must be directed towards the most depressed area of the most prominent plateau and then, with the arm of the rod
in position “0”, probe the most depressed area of the plateau with the most wear. If in order to probe on the most depressed plateau it is necessary to
move the system down, this measurement must be noted down.

Note:
For the “0-10” rod, which is only used for primary semi-constrained surgery, the “0” probe coincides with the deepest point of the rod, unlike the “0-8”
and “0-12” rods used for revision surgery.

1.3 Tibial resection

Once the tibial cutting guide is in the correct position, it is fixed to the tibia using pins. Then the telescopic intramedullary system is removed (loose-
ning all of the fixation screws, moving to the end of the stroke of the thread of the tibial cutting guide and pulling up the telescopic system), and the
intramedullary system is removed.
This is when the tibial cut is made.

Extramedullary system Intramedullary system

Second line of parallel pins

for “Recut +2”

First line of
parallel pins

Oblique pin

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 Surgical Technique

Note:
· Should there be any difficulties when removing the intramedullary system because of an obstructing metaphyseal sleeve, this can be reamed with the
tip of the sleeve inserter/extractor and it can be released by tapping it outwards.
· It is recommended to insert the parallel pins on the first line of pins, using at least three pins and one oblique pin to ensure effective fixation.
· It is recommended that you first put in place the pins at both ends, so that the central pins do not impede the removal of the intramedullary compo-
nents and then, once the intramedullary system components have been removed (diaphyseal reamer and metaphyseal sleeve), install the central pins.
· The parallel pins can be kept, by way of a reference point, to make it possible to make the 2 mm recut.
· If after removing the pins we want to recover this reference point, it is recommended to put back the cutting guide by inserting the probe hook through
the corresponding cutting slot, supporting it on the resected surface and making use of the drill holes which have already been made in order to reinsert
the pins and thus fix the cutting guide in the right position. For greater accuracy when putting back the cutting guide it is recommended to perform the
above action by reassembling the extramedullary telescopic system on the intramedullary system.

1.4 Measuring of the tibial tray

Set 1. Upper tray

After making the cut, when placing the trial templates on the tibial cut, select the size which best suits the bone morphometry of the tibial cut which
has been made.

Trial tibial template

Support handle

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 Set 2. Upper tray

1.5 Measuring of the interline

In order to measure the interline, fit the lower edge of the interline sizing guide’s flange onto the ATT. As the average interline ranges approximately from
25 mm (Size 1: 23 mm, Size 2: 24 mm… Size 5: 28 mm) it is possible to determine the thickness of the tibial insert to be used in advance in order to
maintain the articular interline.

Example:
If “a” is the height from the insertion of the patellar ten-
don with the ATT to the tibial osteotomy, and knowing that
the thickness of the tibial tray is approximately 4 mm and
the interline is approximately 25 mm from the insertion of
the patellar tendon with the ATT, we can conclude that the
thickness of tibial insert “I” to be used must be as follows
in order to maintain the interline:

Thickness of Insert: Interline

(see image)
Tibial Tray
Tibial Cut

Therefore, a 10 or 12 mm tibial insert would be used to

maintain the interline in its position.

Note:
When it is necessary to perform an osteotomy of the TTA to make it possible to dislocate the patella, the height of this insertion will be marked on the
front side of the metaphysis so that measurements can be taken from this mark.

It is essential that the interline is located in the right place in order to ensure proper knee function.

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 Surgical Technique

2. FEMORAL TIME Set 2. Upper tray

Let us consider two situations:

a) Implantation of a semi-constrained TKR on a knee with no previous surgery (primary surgery).
b) Implantation of a semi-constrained replacement in a prosthetic replacement (revision surgery).

2.1 Measuring of the femoral component

Revision surgeries: using revision femoral sizing guides.

Primary surgeries: using the primary femoral sizing guide which will indicate the correct size, supporting the posterior condyles and tapping with the
rod on the anterior cortex. In this case the sizing guide is inserted with the diaphyseal reamer through the centring sleeve. So for primary surgeries,
ream with the diaphyseal reamer and then measure the size of the femoral component.

Note:
· At this moment, check and assess the size which was
previously selected for the tibia (see 1.4.)
· When the sizing gauge is positioned between two sizes,
the smaller size must be selected.

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 Set 0. Upper tray

2.2 Intramedullary fixation

Diaphyseal intramedullary reaming

In order to ensure good stability for the axis of the diaphyseal reamer, which serves as a guide and support during surgery, gradual intramedullary
reaming is performed with a depth according to the length of the stem which is going to be used.

Diameter of the reaming: The recommended diameters for this reaming are normally around Ø9-10 or 11 mm, although the suitability of the final
diameter for the femoral diaphysis to be used is always at the discretion of the surgeon and, through gradual reaming, it may even be close to that
of the inner cortex diameter fitting. This is the case when a 200 mm stem must be inserted.

Depth: Generally, the diaphyseal reamer is inserted up to the second 70-120-200 mark, because at this depth greater stability, accuracy, tighte-
ning and safety are achieved for the installation of the femoral cutting guide. If it is not possible to penetrate this deeply (short femur, fracture
callus which closes the medullary cavity…), at a minimum it must penetrate as far as the 70 mark in order to house a stem which is 70 mm long.

As the femoral time is being performed, the depths must be adjusted to the marks close to the initial F, as indicated in the image below.

Set 0. Lower tray

Reaming guides with cannulated reamers
Deciding the length of the stem which is going to be used prior to the operation, ream with a cannulated reamer to the depth which was chosen, reaming
with an incremental diameter.

Depth: To install a 70 mm stem, penetrate as far as the first 70 mark. If, on the other hand, the stem must be 102 or 200 mm, ream until the second
120-200 mark. As this is the femoral time, pay attention to the depth marks closest to the initial F.

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 Surgical Technique

Set 0. Lower tray

Diameter: Carry out gradual reaming in order to carve the cavity which will house the femoral stem.

F-70 F-70
Cavity to house
stem

Note:
When using a 200 m stem, the diameters of the reamers (diaphyseal and cannulated) will be
the same, because in order to reach a reaming depth of 200 mm, you use part of the length of
the reaming which has already been completed to secure the diaphyseal reamer.

(See other examples of intramedullary reaming according to the length of the stem being
implanted in Annex I)

12
 Set 0. Lower tray

Insertion of the metaphyseal sleeve

Much like for the tibial time, in order to give the system greater possible stability for subsequent assemblies and surgeries, a metaphyseal sleeve is
installed, occupying the position which has been machined with the cannulated reamer and which is subsequently occupied by the femoral stem.

The diameter of the sleeve being used is the same as the diameter of the last cannulated reamer which was used, inserting a short metaphyseal sleeve
if the reaming was performed up to the 70 mark, or a long one if reaming has reached the 120-200 mark.

The sleeves must be inserted with the revision sleeve inserter/extractor, with its threaded cap which protects the extracting thread, at a minimum
depth, as indicated on the axis of the inserter, according to the readings which correspond to the surgical time we are performing (femur) and the type
of surgery being carried out: Semi-Constrained Revision or Primary Semi-Constrained.

Note:
It is recommended to insert the sleeve with its threaded cap (to protect the extracting thread).
When inserting a sleeve of Ø10 mm the inserter must be used without the cap because if this protective cap is used it will exceed the 10 mm
diameter of the sleeve.

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 Surgical Technique

Set 2. Upper tray

2.3 Distal cut

On the axis of the diaphyseal reamer insert the distal cutting mask, which has been installed on the 5° angular guide which crosses the axis.
Then insert the mask until it comes into contact with the distal part of the femur, supporting the mask’s upper visor on its front and secure with threa-
ded pins of Ø 4.4 mm.
Two options can be seen on the cutting mask, which are marked on the cutting slots. Through these you will take into account the readings on the left
to perform “Primary Semi-Constrained” surgery and those on the right for “Semi-Constrained Revision” surgery.

In the case of “Primary” surgery, cut the support area to 8 mm, and for “Revision” surgery cut to 1 mm. We will also find slots marked for additional
recuts of 4, 8 and 12 mm, to enable sanitising or on condylar cuts. In these cases we will use distal supplements with the same thickness as the distal
cut which has been made.

Note:
Before fitting the mask and making the cuts it is advisable to take into account its degree of rotation, perpendicularly aligning the mask with
the tibial axis. This is performed by inserting the “Alignment Bar” through the hole of the “5° Angular Guide”, aligning it with the “tibial crest”.
Alternatively, the mask can also be guided using the femoral epicondyles.

14
2.4 Femoral cuts

Positional adjustment of femoral cutting mask

Remove the distal cutting mask and the angular guide and set up the reamer with its sleeve. Place the cutting guide of the previously selected size on
the handle of the reamer (see 2.1) with the insert positioner and the concentric positioner.
A “Revision” or “Primary” rod has been fitted onto the cutting guide, depending on the type of surgery. Then check whether or not the rod is resting on
the anterior cortex.
REVISION PRIMARY
rod rod

If it is being supported offsetting is not necessary. If it is not being supported remove the concentric positioner and put the eccentric positioner in its
place, rotating it to the left or right until the rod is resting on the frontal area of the femur.

15
 Surgical Technique

Set 3.
Once the rod is touching it, externally rotate the cutting mask by 3°.

Note I:
The medial-lateral displacement resulting from this off-
setting must be carried out as deemed appropriate by
the physician, seeking to centre the femoral component,
although it must be noted that rotating towards the ex-
ternal part has the advantage of reducing the tension on
the patella and is conducive to it being centred on the
femoral component.

Note II:
The cutting mask has housings for 4, 8 and 12 mm dis-
tal supplements, which must be installed to provide pro-
per distal support to the cutting mask, mainly in those
cases where recuts have been necessary on the distal
condyles.

3° of external rotation
With the knee at 90° flexion, and the posterior condyles resting on the surface of the tibia which has previously been cut, insert the 3° external rotation
system into the posterior cutting slots of the cutting guide.

Fit the alignment bar into the hole 3° to the left or right. When this bar is aligned with the axis of the tibia, externally rotate the cutting guide by 3°.
This support also has a hole at 0° which may be used at the discretion of the surgeon.

16
 Alignment Alignment of bar with
bar tibial crest

Tibial axis

Reading of the offset

In this position the offset reading is taken, if an offset has been necessary, because the stem must be fixed to both the trial and final femoral
components.
To take this reading it is important to pay attention to the number of the insert positioner which coincides with the mark of the eccentric positioner.

17
 Surgical Technique

Fixation of the cutting mask with threaded pins

Subsequently, secure the cutting mask to the femur with threaded pins of Ø 4.4 mm and then remove the rod, the concentric or eccentric positioner, the
insert positioner, the metaphyseal sleeve and the diaphyseal reamer.

Note:
It is recommended to insert the thread as far as possible, only leaving one or two threads outside the cortex to ensure that the system has optimal
fixation and stability. The pins have a reference slot which indicates the maximum depth to which the pins should be inserted to avoid problems
when extracting the diaphyseal reamer and the sleeve from inside the intramedullary axis.
If we are making a 12 mm distal recut, the fixation of this condyle will be unstable if we only insert the pin as far as the slot, because only the tip
of the pin will reach the bone. If it is inserted deeper, this will present an obstacle when removing the diaphyseal reamer and sleeve. Therefore, it
is recommended to initially insert the pin as far as the slot and, once the intramedullary components have been removed, finish inserting the pin
until it penetrates the threaded area of the bone.

Set 3.
Making femoral cuts
Fit the appropriate cutting insert for the size of the femur and use it to make frontal, rear and bevel cuts.

Note:
The cutting mask makes it possible to make subsequent
additional cuts at 4 and 8 mm.
To facilitate the identification and correspondence between
sizes of masks and their corresponding cutting inserts, the-
re are colour markers which also coincide with the colour
which will subsequently be used for the trial tibial insert for
the flexo-extension test.

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Intercondylar cut
When the intercondylar cut template has been fitted on the slots of the appropriate cutting insert for to the size of the femur, the cuts are made from
the front of the femur.

Intercondylar cut
template

In order to guide the saws better there is the option of installing the intercondylar insert of the appropriate size and frontally finishing the sides of the
intercondylar box.

With all of the femoral cuts made, remove the cutting mask.

19
 Surgical Technique

Set 2. Lower tray

2.5 Verification of flexo-extension stability

Once the cuts have been made, spacers are used to check the looseness of the system and the alignment of the limb using the corresponding supple-
ments in extension and flexion.

To achieve stability, bilateral supplements are placed on the distal femur at 4, 8 or 12 mm on the femoral spacer (yellow piece) until it stabilises in
extension, or by increasing the thickness of the tibial spacer (blue piece) 2 by 2 mm, bearing in mind that, in both situations, whenever possible you
must compensate the increased thickness with the supplements on the femur to avoid increasing the thickness of the tibial polyethylene inserts, as
this thickness will have been established in order to maintain the position of the interline.

For example:
· If the necessary increase is 2 mm, the thickness of the tibial insert must be increased by 2 mm, because the Genutech CCK system does not have
2 mm femoral supplements.
· If the increase is 4 mm, 4 mm bilateral distal supplements are placed on the femur.
· If the increase is 6 mm, a tibial insert which is 2 mm bigger and 4 mm bilateral distal supplements are placed on the femur.
· Etc…

Set 2: Lower tray

Femoral recutting mask

If, after checking the stability of the joint at flexion and extension it is necessary to make an additional distal femoral recut to release ligamentous
tension, there is a femoral recutting mask which makes it possible to make cuts at a depth of +2 mm, in addition to providing a set of slots at +4, +8
and +12 mm which are designed to delay the cuts to house future supplements from the distal cutting of the femur.

20
This femoral recutting mask is secured using pins of Ø 3.4 mm (the holes marked with arrows indicate the entry position for the inclined pins, which
are necessary to ensure the mask is properly secured).

Set 4. Upper and lower tray

2.6 Reaming to house the femoral post

The necessary distal and posterior supplements are fitted onto the intercondylar mask in order to impact it onto the femoral cuts which have been made,
securing it with 2 pins located on the front edge.

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 Surgical Technique

Set 4. Upper and lower trays

With the intercondylar mask fitted, create the housing for the femoral post by reaming up to the maximum depth possible with the Ø 16 mm reamer
designed for that purpose.

Note:
During this step you must be careful with the potential obstacles for the posterior cortex, above all at small sizes when the offset has been per-
formed close to the lower polar positions.

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 Set 4. Lower tray Set 5

2.7 Assembly of the trial femoral component

Stem: it is recommended to go a size smaller than the reaming diameter, but this will be at the sole discretion of the surgeon. For 70 mm stems
it is recommended to use the same diameter, and for 120 and 200 mm stems, to use a size which is smaller than the reaming diameter to avoid
the “tip effect”. It is assembled by screwing the stem into the distal part of the femoral component, using the screws provided in Box 7 for that
purpose.

Supplements: its pre-mounted screw is screwed into the threaded holes of the femoral component (see Annex VI).

Position between the stem and the femoral component: if it has been necessary to perform an offset, fit the stem while ensuring that the mark of
the stem coincides with the number displayed on the femoral component which originates from the reading which was last taken with the eccentric
positioner on the insert positioner (see 2.4 Reading of the Offset).

Using the femoral component inserter/extractor, insert the femoral component into the femur, making the final adjustments to adapt it to the femoral
cuts. Once inserted, check that it has been adjusted correctly.
Then remove the femoral component, ensuring that the marked number has not changed position, and said offset position will be transferred to the
final prosthesis.

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 Surgical Technique

3. TIBIAL TIME (II)

Set 4. Lower tray Set 5

Optionally, at the discretion of the surgeon, before removing the femoral component, the trial insert of a suitable size is fitted on the tibial tray and
flexion and extension movements are performed to adapt the rotation of the tibial component to the femoral component.
In a suitable place, mark the tibia with an electric scalpel, a mark in the centre of the tibial tray which will help to select the rotational positioning of
the tibial component.

Orientation and fitting of the tibial tray

Having removed the central pins (which had been installed beforehand to enable subsequent tibial recuts), reinsert the diaphyseal intramedullary
reamer and the sleeve which were last inserted into the tibial time (see 1.1).

On its axis install the concentric chisel, and on this place the tibial template of the established size (see 1.4). Furthermore, it must be ascertained
whether the template’s support on the surface of the tibial cut is well contained and centred or, on the contrary, it is off-centre.
In the first case a stem with an offset is not necessary. In the second case it is, as can be seen in the image, the tray is of a suitable size but it is jutting
out, so it would be advisable to move it forwards.

24
In this situation observe which number is showing on the measuring system opposite the longitudinal mark on the chisel. This is the position in which
the stem must be fixed to the tibial tray.

In this position the tibial template is fixed to the tibia with pins. At this moment you can optionally perform a flexo-extension check, by fitting the trial
insert onto the tray, taking care to use the housings marked on the template for pins.

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 Surgical Technique

Box 1. Lower tray

Preparation of the housing for the tibial tray
Once the trial tibial insert has been removed (if this final adjustment of the rotation of the tibial component has been made during flexo-extension), it
is possible to reinforce the tibial template with more pins and then impact the chisel, to the depth which has been marked on it.

Then create the housings for the fins of the keel through a keel impactor which will be placed on the eccentric or concentric keel.

26
Then, remove the entire system.
In the figure below it is possible to see that the intramedullary axis and the housing for the post of the tibial tray are not properly centred, due to the
offset.

Set 1. Lower tray

If tibial supplements have been used, use the hemi-keel (right or left) to assist with the anterior-posterior cut which is made around the two plateaus
so that there is no obstruction for the tibial supplements.

27
 Surgical Technique

Set 6. Upper and lower trays

Fitting of the Tibial Component

The trial tibial tray and the stem are fitted in the predetermined position.

It is then impacted and the corresponding tibial insert is fitted (see annexes VII and VIII).

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4. MOBILITY / STABILITY CHECK
Trial components
The check is carried out with the trial femoral and tibial components fitted to assess the mobility, stability and alignment of the limb.

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 Surgical Technique

5. PATELLA TIME Box 7. Lower tray

Measuring of the thickness

For the prosthetic replacement of the patella there are two factors to consider:

Leave a minimum bone thickness to avoid the risk of a fracture (12-14 mm).

Avoid the hyper pressure which would be caused by a prosthetic knee which is thicker than the original. Therefore, when choosing the size of the
prosthetic patella, you do not only have to consider the diameter which is best suited to the resected bone surface, but also the height of each
patella component measurement:

Diameter 32 mm 34 mm 36 mm 38 mm 40 mm
Height 7 mm 8 mm 9 mm 10 mm 11 mm

Cutting and perforation of patella

Then the osteophytes and synovial tissue around the patella border are removed until the quadriceps and tendon and patella are visible.
With the patella resection clamps closed over the patella so that its anterior cortex rests on the bolts and the turret is set to 12-14 mm, the patella cut is
made.

The mobile arm of the clamp is positioned so that the perforation of the prosthetic pivot is slightly medialised in relation to the centre of the patella.
The perforation is performed with the specific drill bit.

When the trial prosthesis is in place, its travel along the femoral intercondylar channel is assessed with flexo-extension movements.

Note:
If the trial (or prosthetic) patella increases the tension of the extensor apparatus, and therefore the chances of dislocation and wear, a smaller
patella component will be selected to reduce its height.

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6. FINAL IMPLANT
Final check
Fit the final prosthesis (tibial, femoral and patella component) but, prior to fixing the polyethylene insert to the tibial tray with bolts, perform the mobility
and stability test again.

After performing the check and ensuring that it is to be used as the final insert, it is finally fixed to the tibial tray, inserting the metal-reinforced post
of the tibial insert and anterior safety bolt.

Example:

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 Surgical Technique

ANNEX I
EXAMPLES OF DIAPHYSEAL AND CANNULATED REAMING ACCORDING TO THE STEM TO BE
IMPLANTED
TIBIA
Insertion of 70 mm stems in tibia.

T-70 T-70

1st DIAPHYSEAL 2nd CANNULATED

REAMING REAMING

T-70 T-70

Insertion of 70 mm stems in the tibia (greater intramedullary stability).

T-70 T-70

1st DIAPHYSEAL 2nd CANNULATED

REAMING REAMING

T-70 T-70

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Insertion of 120 mm stems in tibia.

T-120 T-120

1st DIAPHYSEAL 2nd CANNULATED

REAMING REAMING

T-120 T-120

Insertion of 120 mm stems in tibia.

T-200 T-200

1st DIAPHYSEAL 2nd CANNULATED

REAMING REAMING

øC
øC= øD
T-200 T-200
øD

The diameters of the diaphyseal reamer and cannulated reamer must be the same, because the 200 mm stem uses part of the depth created by the
diaphyseal reamer.
33
 Surgical Technique

FEMUR
Insertion of 70 mm stems in femur.

F-70

F-70

34
Insertion of 70 mm stems in the femur (greater intramedullary stability).

F-70 - 120 - 200

F-70

35
 Surgical Technique

Insertion of 120 mm stems in femur.

F-120

F-120

36
Insertion of 200 mm stems in femur.

F-200

F-200
øC= øD
øC

øD

The diameters of the diaphyseal reamer and cannulated reamer must be the same, because the 200 mm stem uses part of the depth created by the
diaphyseal reamer. 37
 Surgical Technique

ANNEX II Box 0. Upper tray

RETAINER CABLE OF DIAPHYSEAL REAMERS

If the surgeon believes that there is a possible risk of the diaphyseal reamer being fully inserted into the intramedullary cavity of the bone when can-
nulated reaming is performed, he or she has a retainer cable for these diaphyseal reamers.

Given that the instruments used for the following steps are cannulated, using it will not alter the surgical steps described in these instructions.

ANNEX III
T-HANDLE FOR MANUAL REAMING

The surgeon has a T-handle with quick coupling for “AO hexagonal” connectors to enable manual diaphyseal and cannulated reaming.

Note:
Diaphyseal reamers require the “Tri-lobular > AO-HEX” Adaptor

38
ANNEX IV
WRENCH (14 mm wide)

If vertical movement of the tibial cutting guide is harder than usual, there is a wrench which enables you to easily rotate the sheave of the tibial
cutting guide.

ANNEX V
PIN IMPACTOR

The pin impactor can also be used as an extractor rod, passing it through holes made for that purpose for instruments which, because of the way in
which they are operated, can become stuck or difficult to extract (keel impactors, femoral component inserter/extractor, etc.).

39
 Surgical Technique

ANNEX VI
BALL-HEAD SCREWDRIVER OF Ø 2.5 mm

To facilitate the screwing of the posterior supplements into the femoral components, the Genutech CCK set of instruments has a ball-head screwdriver
(Box 6 – Upper tray) to enable oblique screwing/unscrewing.

40
ANNEX VII
CLIPPING AND EXTRACTION OF TIBIAL INSERTS

Clipping is performed manually, by first resting the back of the insert on the tibial tray and then pressing both pieces until they clip together.

To extract the tibial insert, insert the flat tip of the extractor in one of the slots which is left in the tibial insert when it has been clipped into the tibial
tray, turning it slightly (do not pry open).

41
 Surgical Technique

ANNEX VIII
TIBIAL IMPACTORS

The Genutech CCK set of instruments (Box 6 Upper tray) contains a tibial tray impactor and a second impactor which is designed to enable the fully
assembled tibial component to be impacted, protecting both the tibial post and the surface of the joint. This impactor of the tibial component can also
help to clip the tibial insert into its tray in the (unlikely) event of it being impossible to do so manually.

42 Tibial Tray Impactor Tibial Insert Impactor

ANNEX IX
PATELLAR COMPRESSION CLAMPS

The Genutech CCK set of instruments (Box 7 Lower tray) contains a patellar compression clamp to cause bone cement overflow and maintain pressure
during the necessary setting time so that the patella is properly fitted.

43
 Implants

Cemented femoral
revision component

Ref. D8023120E 1 Ref. D8023110E

Ref. D8023220E 2 Ref. D8023210E
Ref. D8023320E 3 Ref. D8023310E
Ref. D8023420E 4 Ref. D8023410E

4,5 mm offset revision

stem
Ref. D8024101E ø 10 mm 70 mm Ref. D8024401E ø 16 mm 70 mm
Ref. D8024102E ø 10 mm 120 mm Ref. D8024402E ø 16 mm 120 mm
Ref. D8024103E ø 10 mm 200 mm Ref. D8024403E ø 16 mm 200 mm
Ref. D8024201E ø 12 mm 70 mm Ref. D8024501E ø 18 mm 70 mm
Ref. D8024202E ø 12 mm 120 mm Ref. D8024502E ø 18 mm 120 mm
Ref. D8024203E ø 12 mm 200 mm Ref. D8024503E ø 18 mm 200 mm
Ref. D8024301E ø 14 mm 70 mm Ref. D8024601E ø 20 mm 70 mm
Ref. D8024302E ø 14 mm 120 mm Ref. D8024602E ø 20 mm 120 mm
Ref. D8024303E ø 14 mm 200 mm

Straight revision stem

Ref. D8025101E ø 10 mm 70 mm Ref. D8025401E ø 16 mm 70 mm

Ref. D8025102E ø 10 mm 120 mm Ref. D8025402E ø 16 mm 120 mm
Ref. D8025103E ø 10 mm 200 mm Ref. D8025403E ø 16 mm 200 mm
Ref. D8025201E ø 12 mm 70 mm Ref. D8025501E ø 18 mm 70 mm
Ref. D8025202E ø 12 mm 120 mm Ref. D8025502E ø 18 mm 120 mm
Ref. D8025203E ø 12 mm 200 mm Ref. D8025503E ø 18 mm 200 mm
Ref. D8025301E ø 14 mm 70 mm Ref. D8025601E ø 20 mm 70 mm
Ref. D8025302E ø 14 mm 120 mm Ref. D8025602E ø 20 mm 120 mm
Ref. D8025303E ø 14 mm 200 mm

Revision tibial tray

Ref. D8033100E 1
Ref. D8033200E 2
Ref. D8033300E 3
Ref. D8033400E 4
Ref. D8033500E 5

44
 Revision tibial insert

10 mm 18 mm
12 mm 20 mm
14 mm 22 mm
16 mm 24 mm
18 mm 10 mm
20 mm 12 mm
22 mm 14 mm
24 mm 16 mm
10 mm 18 mm
12 mm 20 mm
14 mm 22 mm
16 mm 24 mm
18 mm
20 mm
22 mm
24 mm
10 mm
12 mm
14 mm
16 mm

Distal femoral
supplement
Posterior femoral Ref. D8026150E 1 4 mm
supplement Ref. D8026190E 1 8 mm
Ref. D8026010E 1 4 mm Ref. D8026195E 1 12 mm
Ref. D8026015E 1 8 mm Ref. D8026250E 2 4 mm
Ref. D8026020E 2 4 mm Ref. D8026290E 2 8 mm
Ref. D8026025E 2 8 mm Ref. D8026295E 2 12 mm
Ref. D8026030E 3 4 mm Ref. D8026350E 3 4 mm
Ref. D8026035E 3 8 mm Ref. D8026390E 3 8 mm
Ref. D8026040E 4 4 mm Ref. D8026395E 3 12 mm
Ref. D8026045E 4 8 mm Ref. D8026450E 4 4 mm
Ref. D8026490E 4 8 mm
Ref. D8026495E 4 12 mm

Tibial supplement

Ref. D8032710E 1 8 mm
Ref. D8032715E 1 12 mm Patellar component
Ref. D8032720E 2 8 mm
Ref. D8030140E ø 32 mm
Ref. D8032725E 2 12 mm
Ref. D8030150E ø 34 mm
Ref. D8032730E 3 8 mm
Ref. D8030160E ø 36 mm
Ref. D8032735E 3 12 mm
Ref. D8030170E ø 38 mm
Ref. D8032740E 4 8 mm
Ref. D8030180E ø 40 mm
Ref. D8032745E 4 12 mm
Ref. D8032750E 5 8 mm
Ref. D8032755E 5 12 mm

45
 Set of Instruments
Set of Instruments

*
Complete Set of Genutech ® CCK Revision Instruments

Ref. D8501000

Case 0: Ref. D8307100 Genutech ® CCK Set 0. of intramedullary drilling instruments

1 Revision diaphyseal reamer protection Upper tray

6 Revision diaphyseal
Ref. D8271420 reamer
5
Diameter
2 IM awl 1 Ref. D8171009 ø 9 mm
Ref. D8171010 ø 10 mm
Ref. D8210010S
Ref. D8171011 ø 11 mm
3 Quick coupling T-handle key 2 Ref. D8171012 ø 12 mm
AO-HEXAGONAL 6
Ref. D8171013 ø 13 mm
Ref. D8271475 3
4 Ref. D8171014 ø 14 mm
4 Tri-lobular adaptor Ref. D8171015 ø 15 mm
Ref. D8171016 ø 16 mm
Ref. D8271410
Ref. D8171017 ø 17 mm
5 9 mm drill bit
Ref. D8171018 ø 18 mm

Ref. D8210020

Lower tray

1 Revision cannulated
reamer
Diameter 3 Inserter/extractor of revision sleeves
Ref. D8171110 ø 10 mm 1
2
Ref. D8171112 ø 12 mm Ref. D8271405
Ref. D8171114 ø 14 mm
4 Plug of inserter/extractor of revision
Ref. D8171116 ø 16 mm sleeves
Ref. D8171118 ø 18 mm Ref. D8271406
3 4
Ref. D8171120 ø 20 mm

2 Revision metaphyseal
sleeves
Diameter Length Diameter Length
Ref. D8271010 ø 10 mm 70 mm Ref. D8271110 ø 10 mm 110 mm
Ref. D8271012 ø 12 mm 70 mm Ref. D8271112 ø 12 mm 110 mm
Ref. D8271014 ø 14 mm 70 mm Ref. D8271114 ø 14 mm 110 mm
Ref. D8271016 ø 16 mm 70 mm Ref. D8271116 ø 16 mm 110 mm
Ref. D8271018 ø 18 mm 70 mm Ref. D8271118 ø 18 mm 110 mm
Ref. D8271020 ø 20 mm 70 mm Ref. D8271120 ø 20 mm 110 mm

* This complete set can be supplied in water and airtight containers to maintain their sterility, at the customer's request. Contact your distributor or manufacturer.
8

46
Case 1: Ref. D8307200 Genutech ® CCK Set 1. of tibial instruments

Upper tray

1 Revision telescopic guide system 8 Support handle for tibial

template
Ref. D8277120 9 Ref. D8220520
1 7

2 Support base for revision telescopic 9 14 mm open-end wrench

guide 4 5 6
Ref. D8277122 10 Ref. D8271470
8

10 Distal clamp for tibial guide

3 Revision telescopic guide carriers 11

2 3 Ref. D8220140
Ref. D8277124

11 Revision tibial
4 Revision tibial cutting guide 5 Revision probe axle 6 Primary semi-constrained tibial probe template Size
Ref. D8270301 1
Ref. D8270510 Derecho Ref. D8270608 0-8 mm Ref. D8220270
Ref. D8270302 2
Ref. D8270520 Izquierdo Ref. D8270612 0-12 mm
7 Probe hook Ref. D8270303 3
Ref. D8270304 4
Ref. D8220290 Ref. D8270305 5

Lower tray

1 Revision straight chisel 4 Revision keel

template Size
Ref. D8277200 Ref. D8270401 1
1
Ref. D8270402 2
2 Ref. D8270403 3
2 Revision eccentric chisel Ref. D8270404 4
3
5 Ref. D8270405 5
Ref. D8277205

5 Hemi-keel for revision tibial cut

3 Threaded rod for revision keel
template 4 Ref. D8270810 Right
Ref. D8270400 Ref. D8270820 Left

47
 Set of Instruments
Set of Instruments

Case 2: Ref. D8307300 Genutech ® CCK Set 2. of tibial/femoral instruments

Upper tray
1 Revision interline sizing guide

Ref. D8277140
2 Revision 5° angular guide 4 4 Primary femoral sizing guide
1
Ref. D8271055 Ref. D8271450
3 Revision femoral 3
sizing guide 5 Distal cutting mask
Size
5
Ref. D8271441 1
Ref. D8271050
Ref. D8271442 2 2

Ref. D8271443 3
Ref. D8271444 4
Lower tray
2 Revision femoral spacer
1 Revision tibial spacer
Length
Ref. D8274008
Ref. D8274110 10 mm
Ref. D8274112 12 mm 3 Supplement for spacer
1
Ref. D8274114 14 mm Length
Ref. D8274204 4 mm
Ref. D8274116 16 mm
Ref. D8274208 8 mm
Ref. D8274118 18 mm
Ref. D8274212 12 mm
Ref. D8274120 20 mm
3
2 4
Ref. D8274122 22 mm 4 Revision distal recut mask
Ref. D8274124 24 mm
Ref. D8271455

Case 3: Ref. D8307400 Genutech ® CCK Set 3. of femoral cutting instruments

1 Revision femoral 5 Revision insert positioner 8 Axle alignment 11 Revision cutting

cutting mask Size Length insert Size
Ref. D8270110 1 Ref. D8271060 Rigth Ref. D8271425 250 mm Ref. D8271071 1
Ref. D8270120 2 Ref. D8271065 Left Ref. D8271422 300 mm Ref. D8271072 2
Ref. D8270130 3 Ref. D8210080 400 mm Ref. D8271073 3
Ref. D8270140 4 Ref. D8271074 4

2 Revision distal mask shim 1

Length 11 12 Revision intercondylar
cutting template Size
Ref. D8271204 4 mm 2 3 4

Ref. D8271208 8 mm 12
Ref. D8271091 1

Ref. D8271212 12 mm
5 Ref. D8271092 2
10
6 Ref. D8271093 3
13
3 Revision Ref. D8271094 4
semi-constrained rod Size
7
14
Ref. D8271301 1
9
Ref. D8271302 2 8 13 Revision Intercondylar
cutting insert Size
Ref. D8271303 3 Ref. D8271081 1
Ref. D8271304 4 Ref. D8271082 2
6 Revision concentric chisel 9 Revision horizontal reference rod mask
4 Primary Ref. D8271083 3
semi-constrained rod Size Ref. D8271210 Ref. D8271435 Ref. D8271084 4
Ref. D8271251 1
Ref. D8271252 2
7 Revision eccentric chisel 10 3° rotation system 14 Chisel
Ref. D8271253 3
Ref. D8271254 4 Ref. D8271215 Ref. D8271310 Ref. D8210220

10

48
 Case 4: Ref. D8307500 Genutech ® CCK Set 4. of femoral trial instruments

Upper tray

1 Posterior trial 3 Distal trial

supplement supplement Size Thickness
Size Thickness
Ref. D8126010 1 4 mm Ref. D8126150 1 4 mm

Ref. D8126015 1 8 mm Ref. D8126190 1 8 mm

2
Ref. D8126020 2 4 mm Ref. D8126195 1 12 mm
1
Ref. D8126025 2 8 mm Ref. D8126250 2 4 mm

Ref. D8126030 3 4 mm 3
Ref. D8126290 2 8 mm

Ref. D8126035 3 8 mm Ref. D8126295 2 12 mm

Ref. D8126040 4 4 mm Ref. D8126350 3 4 mm

Ref. D8126045 4 8 mm Ref. D8126390 3 8 mm

Ref. D8126395 3 12 mm
2 2.5 mm hexagonal ball-head screwdriver Ref. D8126450 4 4 mm
Ref. D8126490 4 8 mm
Ref. D8220645
Ref. D8126495 4 12 mm

Lower tray

1 Revision femoral trial 2 Intercondylar mask

components Size Size
Ref. D8113110 Right 1 Ref. D8273110 Right 1
Ref. D8113210 Right 2 Ref. D8273210 Right 2
1
Ref. D8113310 Right 3 Ref. D8273310 Right 3
Ref. D8113410 Right 4 Ref. D8273410 Right 4
3 4 5
Ref. D8113120 Left 1 2 Ref. D8273120 Left 1
Ref. D8113220 Left 2 Ref. D8273220 Left 2
Ref. D8113320 Left 3 Ref. D8273320 Left 3
Ref. D8113420 Left 4 1 Ref. D8273420 Left 4

3 Inserter/extractor of femoral components 4 Femoral impactor 5 Reamer for femoral

component post Diameter
Ref. D8271415S Ref. D8210210 Ref. D8277130 ø 16 mm

49
 Set of Instruments
Set of Instruments

Case 5: Ref. D8307600 Genutech ® CCK Set 5. of stem trial instruments

Upper tray

1 Revision trial offset stem

Diameter Length Diameter Length Diameter Length
Ref. D8176101 ø 10 mm 70 mm Ref. D8176102 ø 10 mm 120 mm Ref. D8176103 ø 10 mm 200 mm
Ref. D8176201 ø 12 mm 70 mm Ref. D8176202 ø 12 mm 120 mm Ref. D8176203 ø 12 mm 200 mm
Ref. D8176301 ø 14 mm 70 mm Ref. D8176302 ø 14 mm 120 mm Ref. D8176303 ø 14 mm 200 mm
Ref. D8176401 ø 16 mm 70 mm Ref. D8176402 ø 16 mm 120 mm Ref. D8176403 ø 16 mm 200 mm
Ref. D8176501 ø 18 mm 70 mm Ref. D8176502 ø 18 mm 120 mm Ref. D8176503 ø 18 mm 200 mm
Ref. D8176601 ø 20 mm 70 mm Ref. D8176602 ø 20 mm 120 mm

Lower tray

1 Revision trial straight stem

Diameter Length Diameter Length Diameter Length
Ref. D8175101 ø 10 mm 70 mm Ref. D8175102 ø 10 mm 120 mm Ref. D8175103 ø 10 mm 200 mm
Ref. D8175201 ø 12 mm 70 mm Ref. D8175202 ø 12 mm 120 mm Ref. D8175203 ø 12 mm 200 mm
Ref. D8175301 ø 14 mm 70 mm Ref. D8175302 ø 14 mm 120 mm Ref. D8175303 ø 14 mm 200 mm
Ref. D8175401 ø 16 mm 70 mm Ref. D8175402 ø 16 mm 120 mm Ref. D8175403 ø 16 mm 200 mm
Ref. D8175501 ø 18 mm 70 mm Ref. D8175502 ø 18 mm 120 mm Ref. D8175503 ø 18 mm 200 mm
Ref. D8175601 ø 20 mm 70 mm Ref. D8175602 ø 20 mm 120 mm

12

50
 Case 6: Ref. D8307700 Genutech ® CCK Set 6. of tibial trial instruments

Upper tray
1 Revision trial tibial tray
Size
Ref. D8133100 1
3 Tibial tray impactor
Ref. D8133200 2
1
Ref. D8133300 3 Ref. D8220615
Ref. D8133400 4
Ref. D8133500 5 4 Tibial component impactor
2

2 Trial tibial Ref. D8220610

supplement Size Thickness
Ref. D8132710 1 8 mm 3 4 5 5 Tibial insert extractor
Ref. D8132715 1 12 mm
Ref. D8220620S
Ref. D8132720 2 8 mm
Ref. D8132725 2 12 mm
Ref. D8132730 3 8 mm
Ref. D8132735 3 12 mm
Ref. D8132740 4 8 mm
Ref. D8132745 4 12 mm
Ref. D8132750 5 8 mm
Ref. D8132755 5 12 mm
Lower tray

1 Revision trial tibial

insert Size Length Size Length Size Length Size Length
Ref. D8161100 1 10 mm Ref. D8162100 2 10 mm Ref. D8163100 3 10 mm Ref. D8164100 4 10 mm
Ref. D8161120 1 12 mm Ref. D8162120 2 12 mm Ref. D8163120 3 12 mm Ref. D8164120 4 12 mm
Ref. D8161140 1 14 mm Ref. D8162140 2 14 mm Ref. D8163140 3 14 mm Ref. D8164140 4 14 mm
Ref. D8161160 1 16 mm Ref. D8162160 2 16 mm Ref. D8163160 3 16 mm Ref. D8164160 4 16 mm
Ref. D8161180 1 18 mm Ref. D8162180 2 18 mm Ref. D8163180 3 18 mm Ref. D8164180 4 18 mm
Ref. D8161200 1 20 mm Ref. D8162200 2 20 mm Ref. D8163200 3 20 mm Ref. D8164200 4 20 mm
Ref. D8161220 1 22 mm Ref. D8162220 2 22 mm Ref. D8163220 3 22 mm Ref. D8164220 4 22 mm
Ref. D8161240 1 24 mm Ref. D8162240 2 24 mm Ref. D8163240 3 24 mm Ref. D8164240 4 24 mm

13

51
 Set of Instruments
Set of Instruments

Case 7: Ref. D8307800 Genutech ® CCK Set 7. of patella tools/instruments

Upper tray

1 Pin extractor 5 Headless pin 7 Fixation screw for trial 9 Tornillo suplemento tibial
Diameter Length tibial tray de prueba
Ref. D8220280 Ref. D8210166 ø 3,4 mm 80 mm Ref. D8232600 Ref. D8132760 8 mm
Ref. D8132762 12 mm

2 Pin extracting/impacting auxiliary rod

1 2
Ref. D8271460

10 AO drill adaptor
3 4
3 Pin with head 5 6
Ref. A1700390 AOHEX
Diameter Length
8
Ref. D8210161 ø 3,4 mm 30 mm 9

Ref. D8210162 ø 3,4 mm 40 mm 11

11 Screwdriver
7 10
Ref. D8210160 ø 3,4 mm 55 mm 12
Ref. D8220635S 2,5 mm

6 Revision threaded
pin Diameter Length *
4 Headless support 8 Support handle for fixing bolt 12 Torque wrench 9N
pin Diameter Length Ref. D8210172 ø 4,4 mm 75 mm
Ref. D8210165 ø 3,4 mm 55 mm Ref. D8210171 ø 4,4 mm 100 mm Ref. D8220530 Ref. D8277250 4,5 mm
*The reference doesn´t correspond to
the image.

Lower tray

2 3

1 Drill bit for patella 2 Clamp for patellar resection 3 Clamp for patella 4 Trial patella
Diameter
Ref. D8230120 Ref. D8230110 Ref. D8230130 Ref. D8130140 ø 32 mm
Ref. D8130150 ø 34 mm
Ref. D8130160 ø 36 mm
Ref. D8130170 ø 38 mm
Ref. D8130180 ø 40 mm

52
 0086

0318
IROGEKCA11 / 07-2015 © Rev. 1
El marcado CE es válido únicamente si también está impreso en la etiqueta del producto.