OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM

K982798 · Osteonics Corp. · KWQ · Mar 25, 1999 · Orthopedic

Device Facts

• Record ID: K982798
• Device Name: OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
• Applicant: Osteonics Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® ACCP System is intended for anterior intervertebral screw fixation of the cervical spine for the following indications: - 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

Device Story

Osteonics® ACCP System is an anterior cervical plating system; provides stabilization for cervical spine fusion. Device features monoblock or modular designs (two- or three-piece); lengths 24mm to 100mm. Surgeon places plate longitudinally on cervical spine; affixes with unicortical bone screws. Slotted locking screw holes allow surgeon to adjust plate position to apply compression to specific spinal areas; locking screws tightened post-adjustment to maintain compression. Used in clinical/surgical settings by orthopedic or neurosurgeons. System aids in achieving successful fusion; benefits patients by stabilizing spinal segments during healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: ASTM F-136-96 titanium alloy. Design: Monoblock or modular (two/three-piece) anterior cervical plate. Dimensions: 24mm to 100mm lengths. Fixation: Unicortical bone screws. Mechanism: Slotted locking screw holes for compression adjustment. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring anterior intervertebral screw fixation of the cervical spine due to degenerative disc disease, spinal cord decompression following 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

• Synthes anterior cervical plates

Submission Summary (Full Text)

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3/25/99

ATTACHMENT 10

11982798

## 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® ACCP SYSTEM

| Submission Information | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------|
| Name and Address of the Sponsor<br>of the 510(k) Submission: | Osteonics Corporation<br>59 Route 17<br>Allendale, NJ 07401-1677<br>201-825-4900 |
| Contact Person: | Kate Sutton<br>Regulatory Affairs Specialist |
| Date Summary Prepared: | February 5, 1998 |
| Device Identification | |
| Proprietary Name: | Osteonics® Anterior Cervical Compression<br>Plating System |
| 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 components are substantially equivalent to similar anterior cervical plates offered by Synthes.

#### Device Description

The Osteonics® ACCP System is an anterior cervical plate that incorporates a one-piece monoblock design, or a two- or three-piece modular design, depending on plate length, which is measured from end to end. Modular end plate sections are secured to each other using locking screws, and are provided preassembled. Optional bone graft screws are also available for insertion through the center screw hole of the modular plate designs. The Osteonics® ACCP is placed logitudinally on the long axis of the cervical spine and is affixed by unicortical bone screws. The Osteonics® ACCP is available in lengths ranging from 24mm to 100mm. A slotted locking screw hole on the proximal and distal end of each preassembled plate allows the surgeon to adjust the plate in order to apply compression to a specific area along the cervical spine, thus optimizing the compressive forces which aid in achieving a successful fusion. Locking screws are firmly tightened after the surgeon has adjusted the plate to the desired level of compression. All Osteonics® ACCP System components are manufactured from ASTM F-136-96 titanium alloy.

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## Intended Use

The Osteonics® ACCP System is intended for anterior intervertebral screw fixation of the cervical spine for the following indications:

- · 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

## Statement of Technological Comparison

The subject Osteonics® ACCP System components are substantially equivalent in design and intended use to the predicate anterior cervical plates offered by Synthes. The subject anterior cervical plate is manufactured from ASTM F-136-96 titanium alloy, and the predicate anterior cervical plate is manufactured from commercially pure titanium (CPT).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

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

K982798 Re: Osteonics® Anterior Cervical Compression Trade Name: Plating (ACCP) System Regulatory Class: II Product Code: KWQ Dated: February 5, 1999 February 8, 1999 Received:

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 controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ਜੋ 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 In addition, FDA may publish further announcements action. 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.

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#### Page 2 - Ms. Kate Sutton

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.

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 [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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# ATTACHMENT 9

510(k) Number (if known): K 982 7 9 &

Device Name: Osteonics® ACCP System

Indications For Use:

The indications for use of the Osteonics® ACCP System, in keeping with those of other legally marketed anterior cervical plates, are as follows.

The Osteonics® ACCP System is intended for anterior intervertebral screw fixation of the cervical spine for the following indications:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Y

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Diode

(Division Sign-Off)
Division of General Restorative Devices K9827
510(k) Number

(Per 21 CFR 801.109)

OR