← Product Code [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ) · K962162

# DALL-MILES TROCHANTER CABLE SUPERGRIP (K962162)

_Howmedica Corp. · JDQ · Aug 14, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K962162

## Device Facts

- **Applicant:** Howmedica Corp.
- **Product Code:** [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ.md)
- **Decision Date:** Aug 14, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3010
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty. The proximal hooks of the Grip are placed over the top of the trochanter and secured by passing Dall-Miles cables through the holes and crimping them in place.

## Device Story

Bone fixation cerclage system; used for trochanteric reattachment post-osteotomy in total hip arthroplasty. Device consists of a grip component with proximal hooks and cables. Hooks placed over trochanter; cables passed through grip holes and crimped to secure. Modification reduces cable exit angle to minimize stress concentrations. Used by orthopedic surgeons in clinical/OR settings.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Bone fixation cerclage; metallic grip component with cable-based tensioning and crimping mechanism. Design modification reduces cable exit angle to mitigate stress concentrations. Sterilization and material specifications not explicitly detailed in summary.

## Regulatory Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

## Predicate Devices

- Dall-Miles Cable Grip System ([K872224](/device/K872224.md))
- Dall-Miles Cable Grip System ([K900926](/device/K900926.md))
- Biomet Medical Products' BMP Cable System

## Submission Summary (Full Text)

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AUG 14 1996

K96 216 2
510(k) Summary

Proprietary Name: Dall-Miles Trochanter Cable SuperGrip

Common Name: Bone Fixation Cerclage

Classification Name and Reference: Bone Fixation Cerclage
21 CFR 888.3010

Proposed Regulatory Class: Class II
Device Product Code: OR(87) JDQ

For information contact: Frank Maas
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
Telephone: (201) 507-7875
Fax: (201) 507-6870
Date Summary Prepared: 6/3/96

The Dall-Miles Trochanter Cable Grip described in this submission is a modification of the original Dall-Miles Cable Grip cleared in (K 872224). The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty. The proximal hooks of the Grip are placed over the top of the trochanter and secured by passing Dall-Miles cables through the holes and crimping them in place.

The modification to the Grip reduces the angle that the cable exits the Grip, thereby relieving potential stress concentrations in the cable.

The substantial equivalence of the Dall-Miles Trochanter Cable Grip is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's original Dall-Miles Cable Grip System (K 872224 and K 900926) and Biomet Medical Products' BMP Cable System.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K962162](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K962162)

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