← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K964087

# BLOCK STOP WIRES (K964087)

_Ferguson Medical · HTY · Nov 25, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K964087

## Device Facts

- **Applicant:** Ferguson Medical
- **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md)
- **Decision Date:** Nov 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Block Stop Wires device is intended for use in the osteosyntheses of epiphysial fractures with small osteo-articular fragments and for temporary support of dislocations of small articulations.

## Device Story

Internal wire fixation device; used for osteosyntheses of epiphysial fractures with small osteo-articular fragments; provides temporary support for dislocations of small articulations; utilized by surgeons in clinical/OR settings; provides mechanical stabilization of bone fragments.

## Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use similarity to predicate devices.

## Technological Characteristics

Internal wire fixation device; design and function similar to standard Kirschner wires and Steinman pins.

## 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

- Kirschner Medical Wire and Steinman Pins ([K831005](/device/K831005.md))

## Submission Summary (Full Text)

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{0}

FERGUSON
MEDICAL
916-342-4133
FAX: 916-343-4541

NOV 25 1996

10 September 1996

K964087

510(k) SUMMARY

The 510(k) summary information required by 21 CFR 807.92 is as follows:

A. Classification name: Pin, fixation, smooth.
Common/usual name: Fixation wire, fixation pin, and others
Proprietary name: Block Stop Wires

B. Substantial equivalence: Kirschner Medical Wire and Steinman Pins (K831005), and others.

C. Device description: The Block Stop Wires device is an internal wire fixation device to be used on various types of articular fractures.

D. Intended use: The Block Stop Wires device is intended for use in the osteosyntheses of epiphysial fractures with small osteo-articular fragments and for temporary support of dislocations of small articulations.

E. Technological characteristics: The Block Stop Wires device is similar to predicate devices in its design, function, and intended use.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K964087](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K964087)

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