PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT

K963255 · Smith & Nephew, Inc., Orthopaedic Div. · JWH · Jan 2, 1997 · Orthopedic

Device Facts

• Record ID: K963255
• Device Name: PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT
• Applicant: Smith & Nephew, Inc., Orthopaedic Div.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 2, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Profix Plus Tibial insert is designed to work with the Profix Knee System to provide for the option of rotational constraint. The tibial insert is a single use device. The Profix Knee System is for Cemented use only. The Profix Plus Tibial Insert when used with the Profix Knee System is designed for patients with the following indications: 1) Rheumatoid arthritis 2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3) Failed osteotomies, unicompartmental replacement, or total knee replacement. 4) Constrained Systems are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Profix Plus Tibial Insert is also indicated for use where a knee cannot be stabilized by soft tissue release. The Profix Plus Tibial Insert is part of a system that is indicated for use only with cement and is a single use device.

Device Story

Profix Plus Tibial Insert; component of Profix Knee System; provides rotational constraint; single-use; cemented fixation only. Used in primary/revision knee arthroplasty; indicated for patients with ligamentous instability (PCL/collateral ligament deficiency) or failure of prior knee procedures. Implanted by orthopedic surgeons in hospital/OR setting. Device restores joint stability; improves patient mobility; reduces pain associated with degenerative or post-traumatic arthritis.

Clinical Evidence

Bench testing only; device produced acceptable results indicating expected performance.

Technological Characteristics

Tibial insert component; rotational constraint design; single-use; cemented fixation; compatible with Profix Knee System.

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients with compatible age/weight/activity levels. Also indicated for failed osteotomies, unicompartmental replacement, or total knee replacement. Specifically for primary and revision surgery where posterior cruciate ligament and one or both collateral ligaments are absent/incompetent, or where knee cannot be stabilized by soft tissue release. For cemented use only.

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).

Submission Summary (Full Text)

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EXHIBIT 4
12963255

# Summary of Safety and Effectiveness

Smith & Nephew Orthopaedics
JAN - 2 1997

## Profix Plus Tibial Insert

The Profix Plus Tibial insert is designed to work with the Profix Knee System to provide for the option of rotational constraint. The tibial insert is a single use device. The Profix Knee System is for Cemented use only.

The Profix Plus Tibial Insert when used with the Profix Knee System is designed for patients with the following indications:

1) Rheumatoid arthritis

2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.

3) Failed osteotomies, unicompartmental replacement, or total knee replacement.

4) Constrained Systems are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

The Profix Plus Tibial Insert is also indicated for use where a knee cannot be stabilized by soft tissue release. The Profix Plus Tibial Insert is part of a system that is indicated for use only with cement and is a single use device.

This device has been tested and produced acceptable results that indicate that the product should perform well.

CONFIDENTIAL