FIXATION PIN OR ROD

K970036 · United States Surgical, A Division of Tyco Healthc · HTY · Mar 25, 1997 · Orthopedic

Device Facts

• Record ID: K970036
• Device Name: FIXATION PIN OR ROD
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: HTY · Orthopedic
• Decision Date: Mar 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• 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.

Indications for Use

Indicated for fixation of small bone fragments in non-load bearing bones requiring immobilization.

Regulatory Classification

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)

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
[phone]

**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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