®
Redmond
Cervical Implants
BIOACTIVE
Stand Alone
Design
Utilizes the advantages of Titanium and PEEK in one implant
Cervical Implants
Contents
Introduction 2
Indications 2
Contraindications 2
Design Rationale 3
Clinical Outcome 4
Surgical Technique 5-9
Instrument Set 10
Instruments 12
Implants 14
1
Cervical Implants
Introduction
Anterior cervical discectomy and fusion (ACDF) is a commonly employed surgical
technique in the treatment of cervical spondylosis. There had been recent attempts
to enhance interbody cage implants through the use of composite-designs combining
materials titanium (Ti) and polyetheretherketone (PEEK).
Redmond® Cervical Cage utilizes the advantages of titanium and PEEK in one implant.
Indications
• Degenerative disk disease
• Spondylolisthesis and retrolisthesis grade 1
• Spinal stenosis
• Revision operation
• Pseudarthrosis
Contraindications
• Patients with fever or leukocytosis
• Patients with infections associated with the spine (e.g. spondylodiscitis)
• Patients with a history of material allergy or who tend to react to foreign bodies
• Patients with inadequate bone quality or quantity
(e.g. severe osteoporosis, osteopenia, osteomyelitis)
• Spinal fracture
• Spinal tumor
Precautions for use
The application of this system is only performed in a sterile surgical environment at the clinic and
professional spine center. The product may effect by strength and fatigue. The instruments must
be checked for damage during the cleaning and sterilization process and then stored in a dry,
dust-free place.
A-SPINE's instruments are non-sterile, and please refer to "Instruction for Cleaning, Sterilization,
Inspection and Maintenance of Reusable Medical Devices"
2
Cervical Implants
Design Rationale
Titanium and PEEK combined
• Cage components are made of medical grade PEEK
( polyetheretherketone ) and Ti-6Al-4V EL I
• Teeth on the superior and inferior implant surfaces are made
of �tanium with Porous treatment
Porous Titanium Plate
• Excellent early new bone forma�on
• Provides excellent skeletal a�achment
PEEK
Locking Screws
Variable Screws Locking Cap
Self Drilling Self Tapping Oversized
Diameter: 4.0mm Diameter: 4.0mm Diameter: 4.5mm Diameter: 2.5mm
Length: 12 ~18 mm Length: 12~18 mm Length: 12~18 mm
Rescue screws
Angula�on
Screw angula�on 9.5º
(uni-plane)
Ø4.0 screw 40°~60°
Ø4.5 screw 50°
14 A°
Reference chart for
different screws length 50°
by cover the body height 9.5º
and length.
10.0
Screws length are from
11.3 Note:
12,14,16,18 mm 12.6
• The adjustable angle on the 4.0 screw is 40~60 degrees.
13.9
• According to the calculated length: Cage length 12
(L) /mm
matched with L12 screws; The cage length 14 matched
with L14 screws and so forth and so on , its will not
exceed the depth of the fusion cage.
3
Cervical Implants
Clinical Outcome
Cord compression with Myelopathy. Deformity with muti-level.
Redmond® ACDF Fusion Status.
Clinical case-Postoperative
4
Cervical Implants
Surgical Technique
Approach
Patient is in a supine position, the correct operative cervical
spine level done by radiographic check. Approach and
expose the vertebral disc by doing a complete discectomy
through the standard anterior approach to the C spine.
Distraction the vertebral body by caspar distractor, perform
discectomy then prepare the endplates.
Trial Sizing
The correct size of Redmond® Cervical Implants are determined
by inserting the Trials (229-7921 ~ 229-8040) to the disc space.
The Trials have the same shape and size as Redmond® Cervical
Implants, and choose appropriate height of the Trial from short
to high so as not to hurt the vertebral endplate.
Use the Universal Insertor (229-1703) connects the Trials from
Trial Container (20141-046), put the Trials into the disc space
with a proper alignment and carefully check the radiographies.
Note:
It is recommended that you remove the anterior osteophytes
to prevent insertion and positioning interference for reducing
implantation failure.
20141-046 229-79XX / 229-80XX 229-1703
Trial Container Trial Universal Insertor
5
Cervical Implants
Implants Preparation
Guided Inserter Op�on 1 Freehand Inserter Op�on 2
It is highly recommended to use #5-7 insertor Use Universal Insertor(229-1703) for
(229-1701)/#8-10 insertor (229-1702) for cage cage insertion and preparation.
insertion and preparation; these insertors include
guides to limit the screw angle to 50°.
After assembly cage and appropriate insertor, put it onto the
Bone Graft Template (229-2901) and fill bone graft in the
center by using the Bone Graft Impactor (218-3301).
Implantation
Remove the osteophytes and carefully insert the
cage into the distraction segment. When using a
small cage (H5-7), it may be necessary to cut some of
the front bones to increase the fit between cage and
vertebral.
Note:
The implantation position of the Cage must be aligned with the
anterior edge of the vertebral body.
229-1701 / 229-1702 229-1703 229-2901 218-3301
#5-7 Insertor Universal Insertor Bone Graft Template Bone Graft Impactor
#8-10 Insertor
6
Cervical Implants
Screw Hole Preparation Option
Step 1 Screw hole preparation
Guided inserter Op�on
The use of the #5-7 Insertor/#8-10
Insertor,awl and tap must be matched
with Telescopic
Sleeve (229-2301) to ensure that the 12mm
preparing trajectory is correct.
Freehand inserter Op�on
If the Universal Insertor is used, the Angle
Guide(229-1101) can be used as a guide
to prepare the screw trajectory.
Step 2 Bone Screw Insertion
Use the Flexible Screw Holder (229-1301) to load the screw
from the Screw Container (20141-040) and insert screw into
trajectory.
Note:
If the selected screw length exceeds the length of the cage, there must be at least 2 mm of space
between the cage and the posterior edge of the vertebral body to avoid nerve damage.
Guided Screw Inser�on Op�on Freehand inserter Op�on
Use the Flexible Screwdriver (229-3301) Use the Universal Insertor (229-1703) to connect
to tighten the screws. the implant and tighten the screw by Flexible
Screwdriver (229-3301)
229-2301 229-1101 229-1301 229-3301 229-3302
Telescopic Sleeve Angle Guide Flexible Screw Holder Flexible Screwdriver Screwdriver
7
Cervical Implants
Direct Screw Insertion Option
Use the Flexible Screw Holder (229-1301) to load
the screw from the Screw Container (20141-040)
and insert screw into trajectory.
Guided Screw Inser�on Op�on Freehand Screw Inser�on Op�on
Use the Flexible Screwdriver (229-3301) Use the Universal Insertor (229-1703)
to tighten the screws. connects the implant and tighten the screw
by Flexible Screwdriver (229-3301)
Note:
Flexible Screw Holder cannot be used for final tightening.
Cat.No. Description
229-1301 Flexible Screw Holder
20141-040 Screw Container
229-3301 Flexible Screwdriver
229-3302 Screwdriver
229-1701 #5-7 Insertor
229-1702 #8-10 Insertor
229-1703 Universal Insertor
8
Cervical Implants
Securing the Locking Cap
Use the Cap Holder (229-1302) to capture the
Locking Cap from the Locking Cap Container
(18140-046) and screw to the central hole of
Redmond® Cervical Implant for preventing
screws back-out.
The locking cap is finally tightened by the
screwdriver.
Note:
The Cap Holder cannot be used for final tightening,
otherwise it will damage the grab function.
Cat.No. Description
229-1302 Cap Holder
18140-046 Locking Cap Container
STERILIZATION
The Redmond cervical instruments and screws are delivered non sterile. Before use needed
cleaned and sterilized recommended to be steam sterilized by the hospital using the
following process parameters:
Steam Wrapped Gravity Cycle at Steam Wrapped Gravity Cycle at 121 ℃/ 250 ℉ for 30
minutes, dry time 30 minutes.
Steam Wrapped Dynamic-Air-Removal (Vacuum) Cycle at 132 ℃/ 270 ℉ for 4 minutes, dry
time 30 minutes.
The cage had been sterilized by gamma radiation at least 25 kGy dose.
It should avoid contaminating while operation process. It is necessary to exchange our
product if the packaging has been broken without reason.
If need more function, please refer to "Reprocessing Manual" from A-SPINE's website
(http://www.aspine.com.tw/).
9
Cervical Implants
Instrument Set
1
2
3
4
5
6
7
8
9
10
11
12
Instrument Tray 1
Cat.No. Description Q’nty
1 229-1702 #8-10 Insertor 1
2 229-2301 Telescopic Sleeve 4
3 229-1701 #5-7 Insertor 1
4 229-0202 2.0mm Drill Bit Awl 1
5 229-0201 2.0mm Flexible Drill Bit Awl 1
6 229-0502 2.8mm Tap 1
7 229-0501 2.8mm Flexible Tap 1
8 229-1302 Cap Holder 1
9 229-1301 Flexible Screw Holder 1
10 229-3302 Screwdriver 1
11 229-3301 Flexible Screwdriver 1
12 229-1101 Angle Guide 1
10
Cervical Implants
13
14 15
18
17
16
Instrument Tray 2
Cat.No. Description Q’nty
13 229-1703 Universal Insertor 2
14 218-3301 Bone Graft Impactor 1
15 18140-046 Locking Cap Container 1
16 229-2901 Bone Graft Template 1
17 20141-040 Screw Container 1
18 20141-046 Trial Container 1
11
Cervical Implants
Instruments
Cat.No. Description
229-0201 2.0mm Flexible Drill Bit Awl
229-0202 2.0mm Drill Bit Awl
229-0501 2.8mm Flexible Tap
229-0502 2.8mm Tap
229-3301 Flexible Screwdriver
229-3302 Screwdriver
229-1701 #5-7 Insertor
229-1702 #8-10 Insertor
229-1703 Universal Insertor
229-1101 Angle Guide
229-1301 Flexible Screw Holder
229-1302 Cap Holder
229-2301 Telescopic Sleeve
218-3301 Bone Graft Impactor
12
Cervical Implants
Instruments
Cat.No. Description
18140-046 Locking Cap Container
229-2901 Bone Graft Template
20141-040 Screw Container
20141-046 Trial Container
99900-046 Redmond Cervical Case with Metal Lid
99901-046 Redmond Cervical Instrument Case * (Optional with plastic lid)
Trials (Angle 5°) Trials (Angle 8°)
Category W / 14mm W / 15mm W / 17mm W / 18mm W / 20mm W / 15mm W / 17mm W / 18mm
H / mm L / 12mm L / 12mm L / 14mm L / 15mm L / 16mm L / 18mm L / 14mm L / 15mm L / 16mm
5 229-7918* 229-7921 229-7923 229-7934 229-7940
6 229-7919* 229-7941 229-7943 229-7954 229-7960 229-8263 229-8274 229-8280
7 229-7920* 229-7961 229-7963 229-7974 229-7980 229-8401* 229-8283 229-8294 229-8300
8 229-7981 229-7983 229-7994 229-8000 229-8402* 229-8303 229-8314 229-8320
9 229-8001 229-8003 229-8014 229-8020 229-8403* 229-8323 229-8334 229-8340
10 229-8021 229-8023 229-8034 229-8040 229-8343 229-8354 229-8360
*Coming soon
13
Cervical Implants
Implants
Redmond® Cervical Implants Speification
Angle 5°
Category W / 14mm W / 15mm W / 17mm W / 18mm W / 20mm
H / mm L / 12mm L / 12mm L / 14mm L / 15mm L / 16mm L / 18mm
5 1051-55428H* 1051-55528H 1051-55548H 1051-55758H 1051-55868H
6 1051-56428H* 1051-56528H 1051-56548H 1051-56758H 1051-56868H
7 1051-57428H* 1051-57528H 1051-57548H 1051-57758H 1051-57868H 1051-57088H*
8 1051-58528H 1051-58548H 1051-58758H 1051-58868H 1051-58088H*
9 1051-59528H 1051-59548H 1051-59758H 1051-59868H 1051-59088H*
10 1051-50528H 1051-50548H 1051-50758H 1051-50868H
*Coming soon
Angle 8°
Category W / 15mm W / 17mm W / 18mm
H / mm L / 14mm L / 15mm L / 16mm
6 1051-86548H 1051-86758H 1051-86868H
7 1051-87548H 1051-87758H 1051-87868H
8 1051-88548H 1051-88758H 1051-88868H
9 1051-89548H 1051-89758H 1051-89868H
10 1051-80548H 1051-80758H 1051-80868H
Variable Screw Locking Cap
Ø /mm Cat.No Self-Drilling Cat.No
1053-128
1052-03038
1053-148
4.0
1053-168
1053-188
Ø /mm Cat.No Self Tapping
1054-128
1054-148
4.0
1054-168
1054-188
Ø /mm Cat.No Oversized
1057-128
1057-148
4.5
1057-168
1057-188
14
A-SPINE Asia Co.,Ltd.
20F., No.80, Sec�on 1, Chenggong Road, Yonghe District,
New Taipei City 234634, Taiwan
Tel:+886-2-2926-7088 Fax:+886-2-2926-7396
E-mail:[email protected] www.aspine.com.tw T-PDS-008-FE/2022-12-19
