HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT

K955871 · Howmedica Corp. · LPH · Mar 22, 1996 · Orthopedic

Device Facts

• Record ID: K955871
• Device Name: HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
• Applicant: Howmedica Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Howmedica® Asymmetric Stem Femoral Component is intended for use in the primary and secondary reconstruction of the head and neck portion of the femur.

Device Story

Femoral component of total hip system; used in primary/secondary reconstruction of femoral head and neck; manufactured from forged cobalt-chromium-molybdenum (Vitallium) alloy; features anatomic design, circumferential porous coating, collared/collarless options, and distal split; implanted by orthopedic surgeons during hip arthroplasty; provides structural replacement for diseased femoral bone; benefits patient through restoration of joint function.

Clinical Evidence

Bench testing only; finite element analysis performed to evaluate endurance load.

Technological Characteristics

Material: Forged cobalt-chromium-molybdenum (Vitallium) alloy. Design: Anatomic, circumferential porous coating, collared/collarless, distal split. Mechanical testing: Finite element analysis for endurance load.

Indications for Use

Indicated for primary and secondary reconstruction of the head and neck portion of the femur, including primary non-inflammatory degenerative joint disease.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• P.C.A.® E-Series Hip System (Howmedica)
• Straight Stem Femoral Component (Howmedica)
• Anatomic Hip (Zimmer)

Submission Summary (Full Text)

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K955871

# 510(k) Summary

**Trade Name:** Howmedica® Asymmetric Stem Femoral Component
**Common Name:** Femoral Hip Prosthesis
**Classification Name:** Hip Joint Metal/Polymer/Metal, Semi-Constrained, Porous Coated, Uncemented Prosthesis 888.3358

This device is a femoral component of a total hip system. Its substantial equivalence is based on an equivalence in labeling, design and materials to several legally marketed devices including: P.C.A.® E-Series Hip System (Howmedica); Straight Stem Femoral Component (Howmedica) and the Anatomic Hip (Zimmer).

All of the named devices are intended for use in the primary and secondary reconstruction of the head and neck portion of the femur. For the specific indication of primary non-inflammatory degenerative joint disease, the Howmedica® Asymmetric Stem Femoral Component is substantially equivalent to the P.C.A.® E-Series Hip and the Howmedica® Straight Stem Femoral Component. Relative indications and contraindications for use are the same for all of the named devices.

The Howmedica® Asymmetric Stem Femoral Component is manufactured from forged cobalt-chromium-molybdenum (Vitallium®) alloy which is similar to the material used in the P.C.A.® E-Series Hip and the Howmedica® Straight Stem Femoral Component.

Each of the named equivalent hip stems, as well as the Howmedica® Asymmetric Stem Femoral Component, share certain design features as follows: anatomic design (P.C.A. E-Series and Zimmer Anatomic Hips); circumferential porous coating (P.C.A.® E-Series Hip, Howmedica® Straight Stem Femoral Component and the Zimmer Anatomic Hip); collared and collarless versions (P.C.A.® E-Series Hip, Howmedica® Straight Stem Femoral Component and the Zimmer Anatomic Hip) and distal split (Howmedica® Straight Stem Femoral Component and the Zimmer Anatomic Hip).

Finite element analysis of this stem showed that the endurance load exceeds the Semlitsch minimum of 630 lbs.

For information contact:
John Dichiara
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
[phone] - Phone
[phone] - Fax

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