OSTEO BOS SYSTEM IN STAINLESS STEEL

K973204 · Osteonics Corp. · HRS · Sep 25, 1997 · Orthopedic

Device Facts

• Record ID: K973204
• Device Name: OSTEO BOS SYSTEM IN STAINLESS STEEL
• Applicant: Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteo BOS" System in Stainless Steel components are intended for long and small bone fracture fixation.

Device Story

The Osteo BOS System consists of stainless steel bone plates used for fracture fixation of long and small bones. The system includes various plate configurations, including wide, narrow, and one-third tubular plates. These components are intended for surgical use by clinicians to stabilize bone fractures. The device functions as a mechanical fixation system to support bone healing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manufactured from ASTM F-138-92 stainless steel. System includes wide, narrow, and one-third tubular plates in various dimensions (2.7mm to 6.5mm). Mechanical fixation device.

Indications for Use

Indicated for fracture fixation of long and small bones.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes bone plates (unspecified 510(k))

Submission Summary (Full Text)

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USTEDNICS-REG AFFAIRS SEP-19-1997 09:55 FRONI

516

SEP 25 1997 K973204

TO

y
oods Revision

Osteo BOS" System in Stainless Steel

510(k) Premarket Notification

# 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO BOS" SYSTEM IN STAINLESS STEEL

#### 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: | September 19, 1997 |
| Device Identification | |
| Proprietary Name: | Osteo BOS ™ System in Stainless Steel |
| Common Name: | Stainless Steel Plating System |
| Classification Name and Reference: | Plate, Fixation, Bone<br>21 CFR §888.3030 |

### Predicate Device Identification

The subject Osteo BOS® System in Stainless Steel components are substantially equivalent to similar bone plates offered by Synthes.

#### Device Description

The Osteo BOS" System in Stainless Steel components are used for fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from ASTM F-138-92 Stainless Steel and include the following:

- Plate Wide (06.5mm/04.5mm) �
- � Plate - Narrow (06.5mm/04.5mm)
- Plate Wide (04.0mm/03.5mm) .
- One-Third Tubular Plate (e4.0mm/03.5mm) �
- Plate (@2.7mm) �

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Osten BQS " System in Stainless Steel

510(k) Premarket Notification

### Intended Use

The Osteo BOS" System in Stainless Steel components are intended for fracture fixation of long and small bones.

TC

## Statement of Technological Comparison

The subject Osteo BOS" System in Stainless Steel components are substantially equivalent in design and intended use to the predicate bone plates offered by Synthes. Both the subject and predicate plates are manufactured from stainless steel.

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Image /page/2/Picture/1 description: The image shows the 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. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kate Sutton 'Requlatory Affairs Specialist Osteonics 59 Route 17 Allendale, New Jersey 07401-1677

SEP 2 5 1997

Re: K973204 Osteo BOSTM System in Stainless Steel Regulatory Class: II Product Code: HRS Dated: August 25, 1997 Received: August 26, 1997

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 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 (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. ਸੇ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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.

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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,

Colia M. Witton, Ph. D.

a 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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Page 1 of 1

| 510(k) Number (if known): | K973204 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Osteo BOS" System in Stainless Steel

Indications For Use:

The indications for use of the Osteo BOS" System in Stainless Steel bone plates, in keeping with those of other legally marketed bone plates and bone screws, are as follows.

- The Osteo BOS" System in Stainless Steel components are intended for long and small bone ● fracture fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | restorative Devices K973204 |
|--|-----------------------------|

| Prescription Use | X |
|----------------------|-----------------------------|
| (Per 21 CFR 801.109) | OR |
| | Over-The-Counter Use ______ |
| | (Optional Format 1-2-96) |