← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K970036

# FIXATION PIN OR ROD (K970036)

_United States Surgical, A Division of Tyco Healthc · HTY · Mar 25, 1997 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K970036

## Device Facts

- **Applicant:** United States Surgical, A Division of Tyco Healthc
- **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md)
- **Decision Date:** Mar 25, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

Both the Surgical Dynamics™ Bone Pin** and the Poly-Medics Lactosorb® Bone Pin (K953194) are intended for fixation of small bone fragments in non-load bones with appropriate immobilization.

## Device Story

Resorbable fixation pin; used for small bone fragment stabilization in non-load bearing applications; requires external immobilization; supplied in various sizes; intended for surgical use.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Resorbable fixation pin; biosafe material composition; various sizes available; supplied without K-wires.

## 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

- Poly-Medics Lactosorb® Bone Pin ([K953194](/device/K953194.md))

## Submission Summary (Full Text)

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United States Surgical Corporation
510(k) Premarket Notification
Surgical Dynamics™ Bone Pin**
K970036
MAR 25 1997

# 510(k) SUMMARY OF INFORMATION:

**SUBMITTER:** United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856
(203) 845-1000

**CONTACT PERSON:** Melissa Mazzoni

**DATE PREPARED:** December 31, 1996

**CLASSIFICATION NAME:** Pin, Fixation, Smooth or threaded metallic bone fixation fastener

**COMMON NAME:** Fixation Pin or Rod

**PROPRIETARY NAME:** Trademark name not yet determined.

**DEVICE DESCRIPTION:** The Surgical Dynamics™ Bone Pin** is a resorbable fixation pin intended for fixation of small bone fragments in non-load bones with appropriate immobilization. It will be available in a range of sizes and will be supplied without attached K-wires.

**PREDICATE DEVICE:** Poly-Medics Lactosorb® Bone Pin (K953194)

**INTENDED USE:** Both the Surgical Dynamics™ Bone Pin** and the Poly-Medics Lactosorb® Bone Pin (K953194) are intended for fixation of small bone fragments in non-load bones with appropriate immobilization.

**MATERIALS:** Both the Surgical Dynamics™ Bone Pin** and the Poly-Medics Lactosorb® Bone Pin (K953194) are comprised of biosafe materials.

** Trademark name not yet determined.
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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K970036](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K970036)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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