SYNTHES ANTERIOR CSLP SYSTEM

K030866 · Synthes (Usa) · KWQ · Apr 18, 2003 · Orthopedic

Device Facts

• Record ID: K030866
• Device Name: SYNTHES ANTERIOR CSLP SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Anterior CSLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: 1. Spondylolisthesis 2. Fracture 3. Spinal stenosis 4. Tumor 5. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).

Device Story

The Synthes Anterior CSLP System is a spinal fixation device consisting of titanium plates, expansion-head screws, and locking screws. It is designed for surgical implantation to the anterior cervical spine (levels C2-C7). The system provides mechanical stabilization of the vertebral bodies. It is used by surgeons in an operating room setting to treat conditions such as fractures, tumors, or degenerative disc disease. The device functions as a structural implant to facilitate spinal fixation; it does not involve electronic inputs, software, or automated processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium spinal fixation system consisting of plates, expansion-head screws, and locking screws. Designed for anterior cervical spine (C2-C7) fixation. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring anterior screw fixation to the cervical spine (C2-C7) for spondylolisthesis, fracture, spinal stenosis, tumor, or degenerative disc disease (neck pain of discogenic origin confirmed by history and radiography).

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Synthes Anterior Cervical Vertebrae Plate System (K945700)

Submission Summary (Full Text)

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KO30866 PACE 1/1

Synthes Anterior CSLP System

#### Summary of Safety and Effectiveness Information 3.0

APR 1 8 2003

SYNTHES (U.S.A.) 1380 Enterprise Drive West Chester, PA 19380 [phone] Contact: Jonathan Gilbert 3/18/02

DEVICE: Synthes Spine Anterior CSLP System [formerly known as: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (as part of Synthes Anterior Cervical Vertebrae Plate System, K945700),10/27/97]

## DESCRIPTION

The Synthes Anterior Cervical Vertebrae Plate System including the Small Stature Anterior Cervical Vertebrae Plate System consists of plates with expansionhead screws and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants of these systems are manufactured from titanium.

## INDICATIONS

The Synthes Anterior CSLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:

- 1. Spondylolisthesis
- 2. Fracture
- 3. Spinal stenosis
- 4. Tumor
- 5. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).

# CLASSIFICATION:

The classification of the subject device is Class II, as per the Code of Federal Regulations, Title 21, Section 888.3060: Spinal intervertebral body fixation orthosis. The product code is KWQ. The Panel code is 87.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The components of the Synthes Spine Anterior CSLP system are the equivalent to components of previously cleared spinal systems. Information on the performance of the subject device compared to the performance of previously cleared spinal systems with similar indications has been provided.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures facing to the right. The figures are represented by curved lines that suggest movement and connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2003

Mr. Jonathan Gilbert Project Manager, Regulatory Affairs SYNTHES Spine 1380 Enterprise Drive West Chester, Pennsylvania 19380

Re: K030866

Trade Name: Synthes Anterior CSLP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 18, 2003 Received: March 19, 2003

Dear Mr. Gilbert:

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.

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### Page 2 - Mr. Jonathan Gilbert

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html.

Sincerely vours,

Mark N. Millkum

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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### Synthes Anterior CSLP System

#### 2.0 Indications for Use Statement

Page 1 of 1

510(k) Number (if known): NA

Device Name: Synthes Anterior CSLP System

## INDICATIONS

The Synthes Anterior CSLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:

- 1. Spondylolisthesis
- 2. Fracture
- 3. Spinal stenosis
- 4. Tumor
- 5. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Mark N. Milkersen

General, Restorative id Neurological Devices

(k) Number K 030866

Synthes Spine Company, L. P. CSLP 510(k)

Confidential March 18, 2003