COLLARLESS POLISHED TAPER HIP PROSTHESIS

K960658 · Zimmer, Inc. · JDI · Jul 16, 1996 · Orthopedic

Device Facts

• Record ID: K960658
• Device Name: COLLARLESS POLISHED TAPER HIP PROSTHESIS
• Applicant: Zimmer, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jul 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• 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.

Indications for Use

Indicated for patients requiring total hip arthroplasty.

Regulatory Classification

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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