OSTEO BOS SYSTEM PRODUCT LINE EXTENSION

K973438 · Osteonics Corp. · HRS · Dec 9, 1997 · Orthopedic

Device Facts

• Record ID: K973438
• Device Name: OSTEO BOS SYSTEM PRODUCT LINE EXTENSION
• Applicant: Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteo BOS™ System product line extension bone plates are intended for internal fracture fixation of various long and small bones. The Kirschner wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, as guide wires in hip pinning, and as fracture fixation devices in certain other small bone fractures.

Device Story

Osteo BOS System product line extension consists of titanium alloy bone plates (Oblique T-Plate, One-Third Tubular Plate) and Kirschner wires with trocar points. Used by surgeons for internal fracture fixation, skeletal traction, and fracture reduction in long and small bones. Device provides mechanical stabilization of bone segments during healing. Plates and wires are implanted during surgical procedures. Benefits include structural support for bone alignment and fracture stabilization.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material comparison to legally marketed predicate devices.

Technological Characteristics

Manufactured from titanium alloy. Components include Oblique T-Plate (ø4.0/ø3.5), One-Third Tubular Plate (ø4.0/ø3.5), and Kirschner wire with trocar point. Mechanical fixation device.

Indications for Use

Indicated for internal fracture fixation of long and small bones (plates). Kirschner wires indicated for guide wires in hip pinning, alignment and reduction of long bone fractures, fixation of non-long bone fractures (e.g., olecranon, patella, tibial plateau, small hand/foot, humeral, radial, ulnar), and use with cerclage wire/cable for greater trochanter fractures.

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 and Kirschner wires (no specific 510(k) number provided)

Submission Summary (Full Text)

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Osteo BOS" System - Product Line Extension

510(k) Premarket Notification

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# 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO BOS" SYSTEM PRODUCT LINE EXTENSION

DEC - 9 1997

### 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 9, 1997 |
| Device Identification | |
| Proprietary Name: | Osteo BOS™ System Product Line Extension |
| Common Name: | Plating/Fixation System |
| Classification Name and Reference: | Plate, Fixation, Bone<br>21 CFR §888.3030<br>Smooth or Threaded Metallic Bone<br>Fixation Fasteners<br>21 CFR §888.3040 |

#### Predicate Device Identification

The subject Osteo BOS" System product line extension components are substantially equivalent to similar bone plates and Kirschner wires offered by Synthes.

## Device Description

The Osteo BOS" System product line extension components are used for fracture fixation on various small and long bones. All Osteo BOS" System product line extension components are manufactured from Titanium alloy and include the following:

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- Oblique T-Plate, ø4.0/03.5
- One-Third Tubular Plate, 04.0/03.5
- Kirschner wire with trocar point

## Intended Use

The Osteo BOS" System product line extension bone plates are intended for internal fracture fixation of various long and small bones. The Kirschner wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, as guide wires in hip pinning, and as fracture fixation devices in certain other small bone fractures.

## Statement of Technological Comparison

The subject Osteo BOS" System product line extension components are substantially equivalent in design and intended use to the predicate bone plates and Kirschner wires offered by Synthes. The subject plates are manufactured from Titanium alloy, and the predicate plates are manufactured from CP Titanium. Both subject and predicate Kirschner wires are manufactured from Titanium alloy.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1997

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

K973438 Re : Osteo BOS System Product Line Extension Trade Name: Requlatory Class: II Product Codes: HRS and HTY Dated: September 9, 1997 September 10, 1997 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, Druq, 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, 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 Requlations, 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 Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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.

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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 Other general premarket notification" (21 CFR 807.97). 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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#### 510(k) Number (if known): K 9 - 3 8 8

#### Device Name: Osteo BOS" System Product Line Extension

Indications For Use:

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

The indications for each of the Osteo BOS" System product line extension bone plates are:

- . Internal fracture fixation of long and small bones.
The indications for the Kirschner wires with a trocar point are:

- For use as guide wires in hip pinning procedures. �
- . For use in aligning and reducing long bone fractures.
- For use in securing non-long bone fractures such as olecranon fractures, patella fractures, . tibial plateau fractures, small hand and foot bone fractures, humeral, and humeral, radial and ulnar fractures, etc.
- . For use with cerclage wire/cable in treating greater trochanter fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X

. . .

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

pcate

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Division of General Restorative Devices rg7348 510(k) Number _