BLOCK STOP WIRES
Device Facts
| Record ID | K964087 |
|---|---|
| Device Name | BLOCK STOP WIRES |
| Applicant | Ferguson Medical |
| Product Code | HTY · Orthopedic |
| Decision Date | Nov 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| 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.
Indications for Use
Indicated for patients with epiphysial fractures involving small osteo-articular fragments and for temporary support of dislocations of small articulations.
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
- Kirschner Medical Wire and Steinman Pins (K831005)
Related Devices
- K961522 — KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN · Synvasive Technology, Inc. · Sep 23, 1996
- K131264 — KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS · Gebr. Brasseler GmbH & Co. KG · Jul 26, 2013
- K192768 — Temporary Fixation Pins · Eisertech, LLC · Dec 26, 2019
- K211508 — Steinmann Pins and Kirschner Wires · Stryker GmbH · Oct 5, 2021
- K073674 — BONE FIXATION WIRE (KIRSCHNER WIRE) · Signal Medical Corp. · Mar 24, 2008
