SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM

K033844 · Synthes (Usa) · KWQ · Feb 5, 2004 · Orthopedic

Device Facts

• Record ID: K033844
• Device Name: SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 5, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Anterior Cervical Compression System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthrosis, and deformity (defined as kyphosis, lordosis or scoliosis).

Device Story

Synthes Anterior Cervical Compression System consists of metal plates and cortical/cancellous screws; designed for anterior fixation to cervical vertebral bodies (C2-C7). Implants provide structural stabilization for spinal pathologies. Used by surgeons in clinical/OR settings. Device functions as mechanical fixation hardware; no software or algorithmic components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium Alloy (Ti-6Al-7Nb) and Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo). Form factor: Plates with cortical and cancellous screws. Mechanical fixation device. No software, energy source, or connectivity.

Indications for Use

Indicated for patients requiring anterior screw fixation to the cervical spine (C2-C7) for conditions including Degenerative Disc Disease (DDD), spondylolisthesis, trauma (fractures), spinal stenosis, tumors (primary/metastatic), failed previous fusions, pseudoarthrosis, and spinal deformity (kyphosis, lordosis, or scoliosis).

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 Locking Plate (K031276)

Submission Summary (Full Text)

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FEB - 5 2004

# 3. 510(k) Summary

| Submitter | Synthes Spine<br>1230 Wilson Drive<br>West Chester, PA 19380 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Susan Lewandowski<br>[phone]<br>[e-mail] |
| Name of the Device | Synthes Anterior Cervical Compression System |
| Predicate Device | Synthes Anterior Cervical Locking Plate - K031276 |
| Device Description | The Synthes Anterior Cervical Compression System consists of<br>plates with cortical and cancellous screws. The plate attaches<br>to the anterior portion of the vertebral body of the cervical<br>spine (levels C2-C7).<br>The implants of these systems are manufactured from Titanium<br>Alloy (Ti-6A1-7Nb) and Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo). |
| Intended Use | Synthes Anterior Cervical Compression System is intended for<br>anterior screw fixation to the cervical spine (C2-C7) for the<br>following indications: Degenerative Disc Disease (DDD),<br>spondylolisthesis, trauma (including fractures), spinal stenosis<br>and tumors (primary and metastatic), failed previous fusions,<br>pscudoarthosis, and deformity (defined as kyphosis, lordosis or<br>scoliosis). |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

Ms. Susan Lewandoski Project Manager, Regulatory Affairs Synthes Spine 1230 Wilson Drive West Chester, Pennsylvania 19380

Re: K033844

Trade/Device Name: Synthes Anterior Cervical Compression System (ACCS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 9, 2003 Received: December 11. 2003

Dear Ms. Lewandowski:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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 - Ms. Susan Lewandoski

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" (21 CFR 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 A. Milliken

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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### 2. Indications for Use Statement

### Special 510(k) Device Modification

#### INTENDED USE STATEMENT

| 510(k) Number (if known): | K033844 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Anterior Cervical Compression System<br>(Modification to Synthes Anterior Cervical Locking Plate) |
| Indications | Synthes Anterior Cervical Compression System is<br>intended for anterior screw fixation to the cervical<br>spine (C2-C7) for the following indications:<br>Degenerative Disc Disease (DDD),<br>spondylolisthesis, trauma (including fractures),<br>spinal stenosis and tumors (primary and metastatic),<br>failed previous fusions, pseudoarthrosis, and<br>deformity (defined as kyphosis, lordosis or<br>scoliosis). |

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

Preseription Use (Per 21 CFR 801.109)

OR Over-the-Counter Use

Mark A. Mulhern

. NEUROLOGICAL EXAMINATION