HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR

K965164 · Howmedica Corp. · LPH · Mar 13, 1997 · Orthopedic

Device Facts

• Record ID: K965164
• Device Name: HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
• Applicant: Howmedica Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Howmedica® Modular Replacement System - Proximal Femur is presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the proximal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the proximal femur is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous hip arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the proximal femur, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.

Device Story

Modular proximal femur prosthesis; used for radical resection and replacement. Fixation via bone cement. Indicated for oncology, severe trauma, and failed hip arthroplasties. Implanted by orthopedic surgeons in clinical/surgical settings. Device restores structural integrity of proximal femur following resection.

Clinical Evidence

Bench testing only; includes modular taper testing and fatigue testing of the proximal femur component.

Technological Characteristics

Modular proximal femur prosthesis; metallic construction; fixation via bone cement.

Indications for Use

Indicated for patients requiring radical resection and replacement of the proximal femur due to oncology, severe trauma, or failed previous hip arthroplasties. Fixation achieved via bone cement.

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

• Howmedica Modular Replacement System - Proximal Femur (K952970)

Submission Summary (Full Text)

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K965164
510(k) Summary
MAR 13 1997

## Device: Howmedica® Modular Replacement System - Proximal Femur

The Howmedica® Modular Replacement System - Proximal Femur is presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the proximal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the proximal femur is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous hip arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the proximal femur, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.

A comparison to other legally marketed products was made, and testing of the modular tapers and fatigue testing of the proximal femur was presented.

## For information contact:

Margaret F. Crowe
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
[phone]