UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

K082273 · Depuy Spine, Inc. · KWQ · Sep 10, 2008 · Orthopedic

Device Facts

• Record ID: K082273
• Device Name: UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 10, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Device Story

UNIPLATE Anterior Cervical Plate System consists of titanium alloy plates and screws; used for anterior cervical intervertebral body fixation to provide stability following fusion. System includes manual surgical instruments. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of cervical spine segments C2-T1. Benefits patient by maintaining alignment and facilitating fusion in cases of trauma, degeneration, or instability.

Clinical Evidence

Bench testing only. Performance data per ASTM F 1717 submitted to characterize system components.

Technological Characteristics

Materials: ASTM F 136 implant grade titanium alloy. Components: plates and screws. Mechanical fixation system. No software or electronic components.

Indications for Use

Indicated for patients (C2-T1 levels) requiring anterior cervical intervertebral body fixation for stability following fusion. Conditions: symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis/lordosis, tumor, degenerative disc disease, spinal stenosis, re-operation for failed fusion, or post-surgical instability.

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

• UNIPLATE Anterior Cervical Plate System (K042544)
• EAGLE Anterior Cervical Plate System (K040197)

Submission Summary (Full Text)

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5.

| 510(K) SUMMARY | | | SEP 10 2008 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Submitter: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 | | |
| Contact Person: | Frank Jurczak<br>Regulatory Affairs Associate<br>Voice: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] | | |
| Date Prepared: | August 8, 2008 | | |
| Device Class: | Class II | | |
| Classification Name: | Spinal intervertebral body fixation orthosis<br>per 21 CFR §888.3060 | | |
| Classification Panel: | Orthopedics | | |
| FDA Panel Number: | 87 | | |
| Product Code(s): | KWQ | | |
| Proprietary Name: | UNIPLATE Anterior Cervical Plate System | | |
| Predicate Devices: | UNIPLATE Anterior Cervical Plate System (K042544)<br>EAGLE Anterior Cervical Plate System (K040197) | | |
| Device Description: | The UNIPLATE Anterior Cervical Plate System consists of<br>an assortment of plates and screws<br><br>The UNIPLATE Anterior Cervical Plate System also<br>contains Class I manual surgical instruments and cases that<br>are considered exempt from premarket notification. | | |
| Intended Use: | The UNIPLATE Anterior Cervical Plate System is intended<br>for anterior cervical intervertebral body fixation. This<br>system is indicated for patients in which stability is desired<br>following anterior cervical fusion for the indications listed<br>below. The intended levels for treatment range from C2-T1. | | |

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Special 510(k) Submission - Additions to UNIPLATE Anterior Cervical Plate System

Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

K082223 Page 2002

Manufactured from ASTM F 136 implant grade titanium Materials: alloy.

Performance Data: Performance data per ASTM F 1717 were submitted to characterize the subject UNIPLATE Anterior Cervical Plate System components addressed in this notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

SEP 1 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Depuy Spine, Inc. % Mr. Frank Jurczak Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

> K082273 Trade/Device Name: UNIPLATE Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: II Product Code: KWO Dated: August 08, 2008 Received: August 11, 2008

Dear Mr. Jurczak:

Re:

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. Frank Jurczak

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Submission - Additions to UNIPLATE Anterior Cervical Plate System

## 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KO82273

Device Name: UNIPLATE Anterior Cervical Plate System

Indications For Usc:

The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, turnor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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 A. Melleuson

Neurological Devices
510(k) Number K082273