SYNTHES CERVIFIX/ AXON

K023675 · Synthes (Usa) · KWP · Nov 26, 2002 · Orthopedic

Device Facts

• Record ID: K023675
• Device Name: SYNTHES CERVIFIX/ AXON
• Applicant: Synthes (Usa)
• Product Code: KWP · Orthopedic
• Decision Date: Nov 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CerviFix® System is indicated for the following: - DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies - Spondylolisthesis - Spinal stenosis - Fracture/dislocation - Atlantoaxial fracture with instability - Occipitocervical dislocation - Revision of previous cervical spine surgery - Tumors When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only. Hooks and Rods The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Rods, Clamps, Screws and Nuts The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

Device Story

Synthes CerviFix System is a spinal fixation orthosis consisting of rods, plates, hooks, clamps, screws, and nuts. Implants are constructed from titanium or titanium alloy. Device provides stabilization to promote fusion in cervical and upper thoracic (C1-T3) spine following trauma, fracture, dislocation, or degenerative conditions. System components can be linked to the Synthes Universal Spinal System via parallel connectors and tapered rods. Used by surgeons in clinical settings to stabilize the spine; output is mechanical fixation of spinal segments to facilitate bone fusion and patient recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium or titanium alloy. Components: Rods, plates, hooks, clamps, screws, nuts, and parallel connectors. Dimensions: 3.5 mm, 4.0 mm cancellous screws; 3.5 mm, 4.2 mm cortex screws. Connectivity: Mechanical linkage to Universal Spinal System. Energy source: None (mechanical).

Indications for Use

Indicated for patients with cervical/upper thoracic (C1-T3) conditions including DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision surgery, or tumors. Screws limited to occipital fixation for cervical conditions and T1-T3 for thoracic conditions.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Reference Devices

• Synthes Universal Spinal System

Submission Summary (Full Text)

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K02 3675 P1/2

Synthes Spine 510(k) Premarket Notification Synthes CerviFix® Line Extension - Axon Components Special 510K

### 8.4 ATTACHMENT IV - 510(K) SUMMARY OF SAFETY AND NOV 2 6 2002 EFFECTIVENESS

### DEVICE

Synthes CerviFix® consists of rods, plate/rods, hooks, clamps, screws, nuts and transconnectors. The implants are composed of Titanium or titanium alloy.

## INDICATIONS

The CerviFix® System is indicated for the following:

- . DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
- Spondylolisthesis ●
- Spinal stenosis ●
- Fracture/dislocation ●
- Atlantoaxial fracture with instability ●
- Occipitocervical dislocation ●
- Revision of previous cervical spine surgery ●
- Tumors ●

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

### Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

### Rods, Clamps, Screws and Nuts

The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

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\$\times 023675. p^{2/2}\$

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

## CONFIDENTIAL

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

Vikki M. Hoffman Senior Regulatory Affairs Specialist Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301

Re: K023675

> Trade/Device Name: Svnthes CerviFix™ System Regulatory Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: KWP Dated: October 31, 2002 Received: November 1, 2002

Dear Ms. Hoffman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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Page 2 – Ms. Vikki M. Hoffman

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

K. Michael Millican

Celia M. Witten, Ph.D., M..D. Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page 1 of 2.

Synthes Spine 510(k) Premarket Notification Synthes CerviFix® Line Extension - Axon Components Special 510K

## 8.2 ATTACHMENT II - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K22 ك

Device Name: Synthes CerviFix®

### Indications for Use:

The CerviFix® System is indicated for the following:

- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation ●
- . Atlantoaxial fracture with instability
- Occipitocervical dislocation
- Revision of previous cervical spine surgery
- . Tumors

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

### Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

### Rods, Clamps, Screws and Nuts

The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

for Mark H. Wilkinson

(Division Sign-On)

Division of Reproductive,
and Neurological Devices

510(k) Number: K023675

CONFIDENTIAL life. 32

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Synthes Spine 510(k) Premarket Notification
Synthes CerviFix® Line Extension - Axon Components Special 510K

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR § 801.109) OR Over-The-Counter Use

Mad McMillan

vision Sign-Off) ision of General, Resta A Neurological Devices

Number K(0.9) 36.73

### CONFIDENTIAL