OSTEONICS ACCP SYSTEM LINE EXTENSION

K992344 · Howmedica Osteonics Corp. · KWQ · Jul 30, 1999 · Orthopedic

Device Facts

• Record ID: K992344
• Device Name: OSTEONICS ACCP SYSTEM LINE EXTENSION
• Applicant: Howmedica Osteonics Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® ACCP System components are intended to provide stabilization at single or multiple levels of the cervical spine, thus aiding in the development of a solid spinal fusion. Additionally, the Osteonics® ACCP System may be used to aid in the restoration of disc height in the presence of a tumor, vertebral trauma, or degenerative disease, pseudarthrosis, or previously failed fusions.

Device Story

Osteonics® ACCP System is an anterior cervical plating system for spinal stabilization; facilitates solid spinal fusion and restoration of disc height. Device features monoblock or modular plate designs; modular sections secured via locking screws. System placed longitudinally on cervical spine; affixed using unicortical bone screws. Used by surgeons in clinical settings for patients with degenerative disease, trauma, tumors, or failed fusions. Provides mechanical stabilization to aid bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate device.

Technological Characteristics

Materials: ASTM F-136-98 (ISO 5832/3) titanium alloy. Design: Anterior cervical plate, monoblock or modular, secured with unicortical bone screws. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for patients requiring cervical spine stabilization due to degenerative disc disease (neck pain of discogenic origin confirmed by history/radiography), decompression following cervical vertebrectomy, trauma (fractures), tumors, pseudarthrosis, 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

• Osteonics® ACCP System

Submission Summary (Full Text)

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# 510(k) PREMARKE T NOTIFICAT SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® ACCP SYSTEM - LINE EXTENSION

| Submission Information | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677<br>201-825-4900 |
| Contact Person: | Kate Sutton<br>Regulatory Affairs Consultant |
| Date Summary Prepared: | July 12, 1999 |
| Device Identification | |
| Proprietary Name: | Osteonics® Anterior Cervical Compression<br>Plating System - Line Extension |
| Common Name: | Anterior Cervical Compression Plate |
| Classification Name and Reference: | Spinal Invertebral Body Fixation<br>21 CFR §888.3060 |

#### Predicate Device Identification

The subject Osteonics® ACCP System Line Extension components are substantially equivalent to the anterior cervical plates in the Osteonics® ACCP System.

#### Device Description

The Osteonics® ACCP System is an anterior cervical single or multi-level plate that incorporates either a monoblock or modular design, which is measured from end to end. Modular end plate sections are secured to each other using locking screws, and are provided preassembled. The Osteonics® ACCP is placed longitudinally on the long axis of the cervical spine and is affixed by unicortical bone screws. All Osteonics® ACCP System components are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.

## Intended Use

The Osteonics® ACCP System components are intended to provide stabilization at single or multiple levels of the cervical spine, thus aiding in the development of a solid spinal fusion.

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Additionally, the Osteonics® ACCP System may be used to aid in the restoration of disc height in the presence of a tumor, vertebral trauma, or degenerative disease, pseudarthrosis, or previously failed fusions.

# Statement of Technological Comparison

The subject Osteonics® ACCP System Line Extension components are substantially equivalent in design and intended use to the monoblock cervical plates in the predicate Osteonics® ACCP System. The subject and predicate anterior cervical plates are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Ms. Kate Sutton Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale. New Jersey 07401-1677

Re: K992344 Trade Name: Osteonics® ACCP System Regulatory Class: II Product Code: KWQ Dated: July 12, 1999 Received: July 14, 1999

Dear Ms. Sutton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 – Ms. Kate Sutton

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): K___________________________________________________________________________________________________________________________________________________

Device Name: Osteonics® ACCP System - Line Extension

Indications For Use:

. 13:40

The indications for the use of the Osteonics® ACCP System are as follows:

- degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed . by patient history and radiographic studies).
- decompression of the spinal cord following total or partial cervical vertebrectomy .
- . trauma (fractures)
- . tumors
- pseudarthrosis .
- failed previous fusions .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------|---------------|
| Division of General Restorative Devices | |
| 510(k) Number | K992344 |
| Prescription Use<br>(Per 21 CFR 801.109) | <div>OR</div> |
| Over-The-Counter Use<br>(Optional Format 1-2-96) | |