← Product Code [JDW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW) · K963433

# THREADED FIXATION PIN (K963433)

_Orthopaedic Biosystems, Ltd. · JDW · Nov 6, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K963433

## Device Facts

- **Applicant:** Orthopaedic Biosystems, Ltd.
- **Product Code:** [JDW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW.md)
- **Decision Date:** Nov 6, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Threaded Fixation Pin is intended for internal alignment and fixation for small bones of the hand and foot.

## Device Story

Threaded fixation pin; titanium alloy construction; used for internal alignment and fixation of small bones in hand and foot; functions similarly to predicate Kirschner wires; physician-operated in clinical setting; provides mechanical stabilization of bone fragments.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Material: Titanium alloy. Form factor: Threaded pin. Function: Internal bone fixation. No electronic or software components.

## 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 Threaded Kirschner Wires

## Submission Summary (Full Text)

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K963433
NOV - 6 1996

# Threaded Fixation Pin 510(k)Summary - Safety and Effectiveness

The proposed device, the Threaded Fixation Pin claims substantial equivalence to a currently marketed device, Synthes Threaded Kirschner Wires. The Synthes Threaded Kirschner Wires and the proposed device are available in Titanium Alloy. Both function as internal alignment and fixation for small bones of the hand and foot and have no significant design differences.

510K-3.WPD
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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K963433](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K963433)

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