DURACON INSET PATELLA WITH CENTRAL PEG

K961482 · Howmedica Corp. · JWH · Jul 5, 1996 · Orthopedic

Device Facts

• Record ID: K961482
• Device Name: DURACON INSET PATELLA WITH CENTRAL PEG
• Applicant: Howmedica Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device, an all-polyethylene concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II 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 concentric dome patella; used as component in total knee system with Duracon and P.C.A. MTK II femoral/tibial components. Implanted via bone cement. Replaces articular surface of patella in primary or revision surgery. Surgeon-operated in clinical setting. Benefits patient by restoring patellofemoral joint function.

Clinical Evidence

Bench testing only. Comparative patello-femoral contact area and shear testing performed against legally marketed predicate device.

Technological Characteristics

Material: Ultra-High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F 648. Design: Concentric dome patella with central peg. Fixation: Bone cement. Energy source: None (mechanical implant).

Indications for Use

Indicated for primary and/or revision replacement of the articular surface of the patella in patients requiring a total knee 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)
• Genesis Biconvex Patella (Smith & Nephew Richards)
• Omnifit All-Polyethylene Patella (Osteonics)
• Miller-Galante II All-Polyethylene Patella (Zimmer)
• Kinematic® II All-Polyethylene Patella (Howmedica)

Submission Summary (Full Text)

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APPENDIX H
JUL - 5 1996
510(k) SUMMARY
X961482

Device: Duracon® Inset Patella with Central Peg

Common Name: Concentric Dome 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 concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II 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) Genesis Biconvex Patella (Smith & Nephew Richards); 4) Omnifit All-Polyethylene Patella (Osteonics); 5) Miller-Galante II All-Polyethylene Patella (Zimmer) and 6) Kinematic® II All-Polyethylene 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 shear testing were presented, with a comparison to a legally marketed device.

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