ANTERIOR COMPACT SYSTEM

K041469 · X-Spine Systems · KWQ · Jul 30, 2004 · Orthopedic

Device Facts

• Record ID: K041469
• Device Name: ANTERIOR COMPACT SYSTEM
• Applicant: X-Spine Systems
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The X-Spine ACP System is intended for anterior screw fixation to the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

Device Story

The X-Spine Anterior Compact Plate (ACP) System consists of titanium alloy plates and bone screws designed for anterior cervical spine fixation. The system is used by surgeons in an operating room setting to provide temporary stabilization of the anterior spine (levels C2 to C7) while spinal fusion develops. The components are provided non-sterile and require sterilization by the user. The device functions as a mechanical construct to support the vertebral body, aiding in the stabilization of the spine to facilitate fusion in patients with various pathologies including trauma, deformity, and degenerative conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by performance data.

Technological Characteristics

Titanium alloy anterior cervical plates and bone screws. Designed for C2-C7 vertebral body attachment. Non-sterile, requires user sterilization. Mechanical fixation device.

Indications for Use

Indicated for temporary stabilization of the anterior cervical spine (C2-C7) during fusion in patients with degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, or failed previous fusions.

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 CSLP System

Submission Summary (Full Text)

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K041469

| JUL 3 0 2004 | PREMARKET NOTIFICATION 510(K) SUMMARY |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | X-Spine Systems<br>7026 Corporate Way, #212<br>Centerville, OH 45459-4288<br>Telephone: [phone]<br>Fax: [phone] |
| Company Contact: | David Kirschman, MD |
| Date: | May 28, 2004 |
| Proposed Proprietary<br>Trade Name: | Anterior Compact Plate (ACP) System |
| Classification Name: | Orthopedics, 888.3060, Class II |
| FDA Product Code<br>Classification: | KWQ |
| Device Description: | The X-Spine Anterior Compact Plate (ACP) System includes<br>titanium alloy anterior cervical plates and bone screws. The plate<br>attaches to the anterior portion of the vertebral body of the cervical<br>spine, levels C2 to C7. The implant components are provided clear<br>and non-sterile. |
| Intended Use: | The X-Spine ACP System is intended for anterior screw fixation to the cervical<br>spine. The system is indicated for use in the temporary stabilization of the<br>anterior spine during the development of cervical spinal fusion in patients with<br>degenerative disc disease (as defined by neck pain of discogenic origin with<br>degeneration of the disc confirmed by patient history and radiographic studies),<br>spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, deformity<br>(defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed<br>previous fusions. |
| Predicate Device: | Synthes CSLP System |
| Performance Data: | Performance data were submitted to characterize the X-Spine ACP System. |

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Image /page/1/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

X-Spine Systems, Inc. C/o Ms. Janet M. Webb MEDVantage, Inc. 121 W. Chestnut Street, #3506 Chicago, Illinois 60610

Re: K041469

Trade/Device Name: X-Spine Systems Anterior Compact Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 28, 2004 Received: June 2, 2004

Dear Ms. Webb:

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 I ca may , more 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 - Ms. Janet M. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in your a counting of substantial equivalence of your device to a legally premated predicated 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 If you dome 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 other general miornitudes 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 yours,
Mark N Milken

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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## Indication for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: X-Spine Systems Anterior Compact Plate System

Indications for Use:

The X-Spine ACP System is intended for anterior screw fixation to the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- Spondylolisthesis, .
- Trauma (i.e., fractures or dislocations), ●
- Tumors, ●
- Deformity (defined as kyphosis, lordosis, or scoliosis) .
- Pseudoarthrosis, and/or .
- Failed previous fusions. .

Prescription Use × Over-The-Counter Use __ or (21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millerson

510(k) Number.

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