DURACON ALL POLYETHYLENE PATELLA II

K961483 · Howmedica Corp. · JWH · Jul 9, 1996 · Orthopedic

Device Facts

• Record ID: K961483
• Device Name: DURACON ALL POLYETHYLENE PATELLA II
• Applicant: Howmedica Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device, an all-polyethylene patella, is intended to be used with the Duracon® femoral and tibial components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.

Device Story

All-polyethylene patellar component; part of Duracon total knee system. Implanted via bone cement; replaces articular surface of patella. Used in primary or revision knee arthroplasty. Orthopedic surgeons perform implantation in clinical/OR setting. Device provides mechanical articulation against femoral component; restores patellofemoral joint function; improves patient mobility/pain relief.

Clinical Evidence

Bench testing only. Testing included patello-femoral contact area and lateral stability assessments.

Technological Characteristics

Material: Ultra-High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F 648. Fixation: Bone cement. Design: All-polyethylene patellar component for use in total knee arthroplasty.

Indications for Use

Indicated for patients requiring primary or revision replacement of the articular surface of the patella as part of a total knee arthroplasty system.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Duracon® Recessed Patella (Howmedica)
• Duracon® All-Poly Patella (Howmedica)
• Duracon® Metal-Backed Patella (Howmedica)
• Kinemax® All Plastic Patella (Howmedica)

Submission Summary (Full Text)

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K961483
510(k) SUMMARY

JUL 9 1996

Device: Duracon® All Polyethylene Patella II

Common Name: All Polyethylene Patella

Classification Name and Reference:
Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis
21 CFR 888.3560

Proposed Regulatory Class: Class II

Device Product Code: JWH (OR)

This device, an all-polyethylene patella, is intended to be used with the Duracon® femoral and tibial components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.

This patella component is similar in intended use, material, design and operational principles to other legally marketed devices. These devices include: 1) Duracon® Recessed Patella (Howmedica); 2) Duracon® All-Poly Patella (Howmedica); 3) Duracon® Metal-Backed Patella (Howmedica) and 4) Kinemax® All Plastic Patella (Howmedica).

All of the devices are fabricated from Ultra-High Molecular Weight Polyethylene which conforms to ASTM Specification F 648. All of the named components have the same intended use. All of the named devices are implanted using bone cement.

Patello-femoral contact area and lateral stability testing were presented.

For information, contact:
Margaret F. Crowe
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
[phone]
Fax: [phone]