← Product Code [HWC](/productcode/HWC) · K962779

# COMPRESSION SCREW (K962779)

_Orthopaedic Biosystems, Ltd. · HWC · Aug 23, 1996 · Orthopedic · SN_

**Canonical URL:** https://fda-staging.innolitics.com/device/K962779

## Device Facts

- **Applicant:** Orthopaedic Biosystems, Ltd.
- **Product Code:** [HWC](/productcode/HWC.md)
- **Decision Date:** Aug 23, 1996
- **Decision:** SN
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Indications for Use

The proposed device, the small bone screw claims substantial equivalence to a currently marketed device, the Synthes mini-fragment bone screw. The Synthes screws and the proposed device are both available in Titanium and Stainless Steel. Both function as internal fixation for bones and have no significant design differences.

## Device Story

Small bone screw; internal fixation for bones; titanium or stainless steel construction; used by orthopedic surgeons in clinical settings; provides mechanical stabilization of bone fragments; facilitates healing.

## Clinical Evidence

Bench testing only; substantial equivalence based on design and material comparison to predicate.

## Technological Characteristics

Materials: Titanium and stainless steel. Form factor: Small bone screw. Function: Internal bone fixation. Mechanical device; no software or energy source.

## Regulatory Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Predicate Devices

- Synthes mini-fragment bone screw

## Submission Summary (Full Text)

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AUG 23 1996
K962779
OBL
ORTHOPAEDIC BIOSYSTEMS LTD., INC.

Small Bone Screw
510(k)Summary
Safety and Effectiveness

The proposed device, the small bone screw claims substantial equivalence to a currently marketed device, the Synthes mini-fragment bone screw. The Synthes screws and the proposed device are both available in Titanium and Stainless Steel. Both function as internal fixation for bones and have no significant design differences.

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**Source:** [https://fda-staging.innolitics.com/device/K962779](https://fda-staging.innolitics.com/device/K962779)

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