DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM

K961186 · Depuy, Inc. · LPH · Sep 17, 1996 · Orthopedic

Device Facts

• Record ID: K961186
• Device Name: DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
• Applicant: Depuy, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Sep 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject DePuy Duraloc Acetabular Cups are intended to be used with DePuy Duraloc polyethylene liners and locking rings to resurface the acetabular socket in cemented or cementless total hip replacement.

Device Story

Acetabular cup prosthesis; used in total hip replacement; resurfaces acetabular socket. Components: porous coated Ti-6Al-4V alloy cups; sizes 38mm-80mm; includes screw holes for adjunctive fixation. Used with Duraloc polyethylene liners and locking rings. Operated by orthopedic surgeons in clinical/OR settings. Provides mechanical stability and articulation surface for hip joint; facilitates patient mobility.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Ti-6Al-4V alloy with CP Titanium porous coating. Form factor: Acetabular cups, 38mm-80mm outer diameter. Features: Screw holes (dome or peripheral) for fixation. System: Semi-constrained cementless prosthesis. No software or electronics.

Indications for Use

Indicated for patients requiring total hip replacement (cemented or cementless) to resurface the acetabular socket.

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 Duraloc® Cementless Acetabular Cup System
• Modified DePuy Acetabular Cup System

Submission Summary (Full Text)

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K961186

# SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:
DePuy Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988

FIRM CONTACT:
Sally Foust
Clinical Research Specialist

TRADE NAME:
DePuy Duraloc® Acetabular Cups - the Bantam, Sector, Polished Sector, Polished Sector, Full Profile Sector, and Deep Profile Solutions Cups

COMMON NAME:
Acetabular Cup Prosthesis

CLASSIFICATION:
888.3358 Hip joint metal/polymer semi-constrained cementless prosthesis

DEVICE PRODUCT CODE:
87 LPH

SUBSTANTIALLY EQUIVALENT DEVICES:
- Depuy Duraloc® Cementless Acetabular Cup System
- Modified DePuy Acetabular Cup System

DEVICE DESCRIPTION AND INTENDED USE:
The subject DePuy Duraloc Acetabular Cups are porous coated Ti-6Al-4V alloy acetabular cups which are available in various sizes, ranging from 38mm to 80mm in outer diameter. All of the cups have screw holes, either dome or peripheral, for adjunctive fixation. All of the DePuy Duraloc Acetabular Cups are intended to be used with DePuy Duraloc polyethylene liners and locking rings to resurface the acetabular socket in cemented or cementless total hip replacement.

BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Duraloc Acetabular Cups are substantially equivalent to the DePuy Duraloc Acetabular 1200 Cups cleared for both cementless fixation and cemented fixation (under the name Modified DePuy Acetabular Cup). All of the subject Duraloc Acetabular Cups and the Duraloc 1200 Cup are manufactured from Ti-6Al-4V alloy with a CP Titanium porous coating. All are available in numerous and varying outer diameters ranging from 38mm to 80mm and are designed to be used with the Duraloc polyethylene liners.

The only differences between the subject DePuy Duraloc Acetabular Cups and the Duraloc 1200 Cups are the addition of smaller outer diameter options with the Bantam cups; the number/and or placement of screw holes with the Bantam, Sector and Deep Profile Solution cups; the polished inner surface of the Polished Sector cups; and the full 180 degree hemispherical profile of the Full Profile Sector and Deep Profile Solution acetabular cups.

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