KINEMATIC II REPLACEMENT TIBIAL INSERTS

K960976 · Howmedica Corp. · JWH · Aug 7, 1996 · Orthopedic

Device Facts

• Record ID: K960976
• Device Name: KINEMATIC II REPLACEMENT TIBIAL INSERTS
• Applicant: Howmedica Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 7, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kinematic® II Replacement Tibial Inserts are intended to be used in the revision of an existing Kinematic® II tibial component assembly. These inserts are intended to be used when the Vitallium baseplate portion of the tibial assembly is well fixed by cement, but the polyethylene bearing portion of the tibial assembly needs revision due to wear or ligament laxity.

Device Story

Replacement tibial inserts for existing Kinematic® II total knee systems; used when Vitallium baseplate remains well-fixed but polyethylene bearing requires revision. Operates as modular component replacement; addresses wear or ligament laxity. Used in clinical orthopedic setting by surgeons. Output is restored joint articulation and stability. Benefits patient by allowing revision of bearing surface without requiring removal of well-fixed tibial baseplate.

Clinical Evidence

Bench testing only. Testing characterized contact area, range of constraint, and attachment strength of inserts to baseplates compared to legally marketed devices.

Technological Characteristics

Polyethylene bearing inserts designed for Vitallium baseplates. Semi-constrained design. Modular attachment mechanism for existing cemented baseplates.

Indications for Use

Indicated for patients requiring revision of the polyethylene bearing portion of a previously implanted, well-fixed Kinematic® II tibial baseplate due to polyethylene wear or ligament laxity.

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

• Kinematic® II Condylar Cruciate Retaining Tibial Component (K823420)
• Kinematic® II Total Condylar Tibial Component (K823420)
• Kinematic® II Stabilizer Tibial Component (K823420)
• P.C.A. Primary Tibial Inserts for Duracon® Baseplates (K936008)
• P.C.A. Modular Tibial Inserts for Duracon® Baseplates (K940861)

Submission Summary (Full Text)

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K960976
510(k) Summary
AUG - 7 1996

Proprietary Name: Kinematic® II Replacement Tibial Inserts

Common Name: Tibial Insert - Total Knee System

Classification Name and Reference: 21 CFR 888.3560
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Proposed Regulatory Class: Class II

Device Product Code: JWH OR(87)

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

The Kinematic® II Replacement Tibial Inserts are intended to be used in the revision of an existing Kinematic® II tibial component assembly. These inserts are intended to be used when the Vitallium baseplate portion of the tibial assembly is well fixed by cement, but the polyethylene bearing portion of the tibial assembly needs revision due to wear or ligament laxity.

The Kinematic® II Replacement Tibial Inserts are equivalent to other legally marketed devices in commercial distribution. These devices are:

1. Kinematic® II Condylar Cruciate Retaining Tibial Component - Howmedica (K823420)
2. Kinematic® II Total Condylar Tibial Component - Howmedica (K823420)
3. Kinematic® II Stabilizer Tibial Component - Howmedica (K823420)
4. P.C.A. Primary Tibial Inserts for Duracon® Baseplates - Howmedica (K936008)
5. P.C.A. Modular Tibial Inserts for Duracon® Baseplates - Howmedica (K940861)

This equivalence is based upon similarities in intended use, material, and design to the legally marketed devices. Testing was presented which characterized the contact area and range of constraint for the subject devices, and the attachment strength of the inserts to the baseplates. Comparisons were made to legally marketed devices.