DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER

K960172 · Depuy, Inc. · LPH · Mar 27, 1996 · Orthopedic

Device Facts

• Record ID: K960172
• Device Name: DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER
• Applicant: Depuy, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The DePuy Porocoat HPS II Hip Prosthesis with Articul-eze taper is indicated for uncemented or cemented use as the femoral components in total hip arthroplasty for replacing the hip joints of patients whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.

Device Story

Femoral component for total hip arthroplasty; replaces damaged hip joints. Design modification of previously cleared Porocoat HPS II; features Articul-eze taper; includes five new stem sizes. Used in orthopedic surgery; implanted by surgeons. Provides structural support for hip joint; enables cemented or cementless fixation. Benefits patients by restoring joint function following degenerative disease or fracture.

Clinical Evidence

Bench testing only.

Technological Characteristics

Femoral hip prosthesis; material: ASTM F75 Co-Cr-Mo alloy. Features porous coating for cementless fixation or use with bone cement. Design includes Articul-eze taper and neck geometry. Dimensions include five new stem sizes (varied diameter and length).

Indications for Use

Indicated for patients requiring total hip arthroplasty due to inflammatory or non-inflammatory degenerative joint disease, fracture, or failure of previous arthroplasty. Suitable for cemented or uncemented femoral fixation.

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

• Porocoat HPS II Hip Prosthesis
• DePuy Vision 5/8 Porocoat AML Hip Prosthesis
• DePuy Porocoat Prodigy Hip Prosthesis
• DePuy Apogee Hip Prosthesis with Porocoat

Submission Summary (Full Text)

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K960172

# SUMMARY OF SAFETY AND EFFECTIVENESS

**NAME OF FIRM:**
DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
MAR 27 1996

**510(k) CONTACT:**
Cheryl Hastings
Manager, Pre-clinical Device Evaluation

**TRADE NAME:**
DePuy Porocoat® HPS II Hip Prosthesis with Articul-eze® Taper

**COMMON NAME:**
Cemented or Cementless Porous Coated Hip

**CLASSIFICATION:**
888.3358 Hip joint metal/polymer semi-constrained porous coated uncemented prosthesis

**DEVICE PRODUCT CODE:**
87LPH

**SUBSTANTIALLY EQUIVALENT DEVICES:**
- Porocoat HPS II Hip Prosthesis
- DePuy Vision 5/8 Porocoat AML Hip Prosthesis
- DePuy Porocoat Prodigy Hip Prosthesis
- DePuy Apogee Hip Prosthesis with Porocoat

**INTENDED USE AND DEVICE DESCRIPTION:**
The Porocoat HPS II Hip Prosthesis with Articul-eze Taper is a design modification of the Porocoat HPS II Hip prosthesis which was previously cleared by FDA for cemented use. The design modification consists of changing the diameter of the taper and neck and adding the intended use of cementless fixation. In addition, five new stem sizes (one increased diameter and four reduced length stems) are being added.

The DePuy Porocoat HPS II Hip Prosthesis with Articul-eze taper is indicated for uncemented or cemented use as the femoral components in total hip arthroplasty for replacing the hip joints of patients whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.

**BASIS OF SUBSTANTIAL EQUIVALENCE:**
The subject Porocoat HPS II Prosthesis with Articul-eze taper is identical to the Porocoat HPS II Prosthesis previously cleared by FDA with the exception of the change in taper/neck design, the addition of a cementless use indication, and the addition of five new sizes. The Articul-eze taper design has previously been incorporated into the DePuy Vision AML Hip Prostheses, the Porocoat Prodigy Hip Prosthesis and the Apogee Hip Prosthesis with Porocoat. The material (ASTM F75 Co-Cr-Mo alloy), manufacturing process, intended use (with the exception of the additional indication of cementless use) and the basic design of the Porocoat HPS II Hip Prosthesis with Articul-eze taper have not changed from those of the Porocoat HPS II Hip Prostheses cleared by FDA in 1984.

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