DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)

K962923 · Depuy, Inc. · LPH · Oct 1, 1996 · Orthopedic

Device Facts

• Record ID: K962923
• Device Name: DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
• Applicant: Depuy, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Graded Porosity AML is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty (THA) 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; used in cemented or uncemented procedures. Device consists of cast Co-Cr-Mo femoral stem with graded porous coating. Coating architecture features five zones of Co-Cr-Mo beads; bead size increases proximally to distally. Stem sintered and HIPed to bond beads. Available in four standard and four modified medial aspect (MMA) sizes. Implanted by orthopedic surgeons to replace damaged hip joints; restores joint function and stability.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological similarities to predicate devices.

Technological Characteristics

Material: Cast Co-Cr-Mo alloy. Design: Femoral hip prosthesis with graded porous coating. Coating: Multi-layered Co-Cr-Mo beads of varying sizes; 5 zones proximally to distally. Manufacturing: Sintered and Hot Isostatic Pressed (HIPed). Configuration: Available in 4 standard and 4 modified medial aspect (MMA) sizes.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to inflammatory or non-inflammatory degenerative joint disease, fracture, or failure of a previous arthroplasty.

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

• DePuy 5/8 Porous Coated AML Hip Prosthesis
• DePuy Proximally Porous Coated AML
• DePuy Solution Hip Prosthesis

Submission Summary (Full Text)

{0}

K962923

OCT 1 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

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

**510(k) CONTACT:**
Cheryl Hastings
Manager, Clinical Affairs

**TRADE NAME:**
DePuy Graded Porosity AML Hip Prosthesis

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

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

**DEVICE PRODUCT CODE:**
87LPH

**SUBSTANTIALLY EQUIVALENT DEVICES:**
- DePuy 5/8 Porous Coated AML Hip Prosthesis
- DePuy Proximally Porous Coated AML
- DePuy Solution Hip Prosthesis

**INTENDED USE AND DEVICE DESCRIPTION:**
The Graded Porosity AML is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty (THA) 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.

It is a fully porous coated, cast Co-Cr-Mo femoral hip prosthesis available in four standard and four modified medial aspect (MMA) sizes. The porous coating consists of Co-Cr-Mo beads of various sizes. The stem is divided proximally/distally into five equal zones. A layer of the smallest beads is applied to the entire stem. A layer of the next larger beads is then applied to the most proximal 4 zones, a layer of the next larger beads is applied to the most proximal 3 zones etc. until the largest beads are applied as the outer layer of beads in the most proximal zone. The stem is sintered and HIPed once to attach all of the beads. The end result is a stem with 5 layers of different sized beads proximally, gradually reducing to 1 layer of the smallest beads distally.

**BASIS OF SUBSTANTIAL EQUIVALENCE:**
The Graded Porosity AML Hip is manufactured from the same material and has the same substrate geometry as the 5/8 Porous Coated and Proximally Porous Coated AML Hip Prostheses. The only difference between the Graded Porosity AML and the 5/8 and Proximally Porous Coated AMLs are that the Graded Porosity AML is a fully porous coated prosthesis and the porous coating is non-homogenous in bead size, pore size and porous coating thickness. The Graded Porosity AML is also similar to the Solution Hip Prosthesis in that both are fully porous coated and both are manufactured from the same material.

000015