← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K961522

# KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN (K961522)

_Synvasive Technology, Inc. · HTY · Sep 23, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K961522

## Device Facts

- **Applicant:** Synvasive Technology, Inc.
- **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md)
- **Decision Date:** Sep 23, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.

## Device Story

Stainless steel Kirschner wires (K-wires) and Steinmann pins; used for bone fragment fixation. Driven through bone via powered rotary device; left implanted to stabilize bone during healing. Single-use; supplied sterile or non-sterile. Used by surgeons in clinical/OR settings to facilitate fracture healing.

## Clinical Evidence

Bench testing only; materials conform to ASTM specifications for medical device use.

## Technological Characteristics

Stainless steel fixation pins/wires; smooth or threaded. Materials conform to ASTM specifications. Powered rotary insertion. Single-use.

## 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

- Standard K-Wires and Steinmann Pins (DePuy, Howmedica, MicroAire, Zimmer)

## Submission Summary (Full Text)

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K961522
SEP 23 1996

ATTACHMENT 11

510(k) SUMMARY

Submitting Company: SYNVASIVE Technology, Inc.
4925 Robert J. Matthews Pkwy.
El Dorado Hills, CA 95762

Telephone: 916-939-3913

Fax: 916-939-3919

Contact Person: Michael G. Fisher
Vice President

Date Prepared: April 8, 1996

Common Product Name: Kirschner Wires (K-Wires) and Steinmann Pins

Classification Name: Smooth or Threaded Metallic Bone Fixation
Fastener (per 21 CFR 888.3040)

Product Description: The subject devices (K-Wires and Steinmann Pins) are stainless steel fixation devices which draw bone fragments together in order to facilitate healing. They will be supplied both as sterile and non-sterile devices and will be labeled for single use.

Intended Use: The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.

Substantial Equivalence: The fixation devices are substantially equivalent to standard K-Wires and Steinmann Pins legally marketed by many companies including DePuy, Howmedica, MicroAire, and Zimmer.

Technological Characteristics: The fixation devices have the same technological characteristics as all of the predicate devices.

Safety and Effectiveness Testing: All materials used in the fixation devices conform with ASTM specifications for medical device use. Material specifications are tested on a design basis and certificates of conformance to specifications are supplied with each material batch.

SYNVASIVE Technology, Inc.
Page 36

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K961522](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K961522)

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