← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K960658

# COLLARLESS POLISHED TAPER HIP PROSTHESIS (K960658)

_Zimmer, Inc. · JDI · Jul 16, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K960658

## Device Facts

- **Applicant:** Zimmer, Inc.
- **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md)
- **Decision Date:** Jul 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3350
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses for total hip arthroplasty consists of femoral stems which are manufactured from forged cobalt-chrome. They are available in a modular configuration. The femoral stems are straight and collarless. The femoral stems may be used with Zimmer femoral heads and corresponding acetabular liners and shells.

## Device Story

Femoral stems for total hip arthroplasty; modular configuration; straight, collarless design. Manufactured from forged cobalt-chrome. Used with Zimmer femoral heads, acetabular liners, and shells. Intended for surgical implantation by orthopedic surgeons in hospital settings to replace diseased or damaged hip joints; restores joint function and mobility; reduces pain.

## Technological Characteristics

Femoral stems; forged cobalt-chrome construction; modular configuration; straight, collarless geometry. Designed for cemented use in total hip arthroplasty.

## Regulatory Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

## Predicate Devices

- Howmedica Exeter Hip
- Zimmer Charnley-Type Hip

## Submission Summary (Full Text)

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Zimmer

510(k) 960658

JUL 16 1996

PO. Box 708

Warsaw, IN 46581-0708

219 267-6131

# Summary of Safety and Effectiveness
## Collarless Polished Taper and Collarless
## Polished Taper LS Hip Prostheses

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

- Submitted by:
Zimmer, Inc.
P.O. Box 708
Warsaw, Indiana 46581-0708

- Prepared by:
Ruth Ann Wood
Senior Regulatory Affairs Associate

- Date:
February 14, 1996

- Trade Names:
Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses

- Classification Name:
Hip Joint metal/polymer semi-constrained cemented prosthesis

- Predicate Devices:
Howmedica Exeter Hip and Zimmer Charnley-Type Hip

- Device Description:
The Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses for total hip arthroplasty consists of femoral stems which are manufactured from forged cobalt-chrome. They are available in a modular configuration. The femoral stems are straight and collarless. The femoral stems may be used with Zimmer femoral heads and corresponding acetabular liners and shells.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K960658](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K960658)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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