P.F.C. CRUCIATE RETAING KNEE SYSTEM

K963117 · Johnson & Johnson Professionals, Inc. · JWH · Nov 6, 1996 · Orthopedic

Device Facts

• Record ID: K963117
• Device Name: P.F.C. CRUCIATE RETAING KNEE SYSTEM
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The P.F.C.® ∑ Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

Device Story

Semi-constrained total knee prosthesis; Stabilized Plus tibial insert components used with existing P.F.C.® ∑ Sigma Knee System. Symmetrical design for left or right knee; features anterior/posterior snap and reinforcing pin for tibial tray interlock. Allows size mixing (up one, same, down one). Used in orthopedic surgery; implanted by surgeons to replace damaged knee joints; provides structural support and joint mobility; benefits patients by alleviating pain and restoring function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semi-constrained total knee prosthesis. Materials: UHMWPE and Titanium. Fixation: Cemented (PMMA). Design: Symmetrical tibial insert with anterior/posterior snap and reinforcing pin. Compatible with existing P.F.C.® ∑ Sigma Knee System components.

Indications for Use

Indicated for patients with severe pain and disability due to permanent structural damage from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma, or failed prior surgical intervention.

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

• P.F.C.® ∑ Sigma Knee System

Submission Summary (Full Text)

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K963117

510(k) Summary

August 9, 1996

NOV - 6 1996

Johnson & Johnson Professional, Inc.
325 Paramount Drive
Raynham, MA 02767-0350

Contact Person: John Ferros
Phone: [phone]

## Name of Device

**Classification Name**: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis has been placed in Class II by the FDA under 21 CFR 888.3560. This falls under the Orthopaedics panel/87.

**Common Name**: Semi-constrained total knee prosthesis.

**Trade Name/Proprietary Name**: P.F.C.® ∑ Sigma Knee System (Stabilized Plus)

**Performance Standards**: No performance standards have been developed for this device.

## Predicate Device

P.F.C.® ∑ Sigma Knee System

## Description of Device

The Stabilized Plus tibial insert components are used with the existing components of the P.F.C.® ∑ Sigma Knee System. The Stabilized Plus tibial insert components have a symmetrical design which can be used for either the left or right knee. The Stabilized Plus tibial insert components have an anterior and posterior snap feature and a reinforcing pin to ensure adequate interlock to the tibial tray. The tibial insert attachment mechanism is identical to the existing TC3 tibial inserts. The Stabilized Plus tibial insert and femoral condylar geometry allow for mixing and matching of sizes: up one size, size to size, and down one size. The device is constructed of UHMWPE, and Titanium.

## Intended Use

The P.F.C.® ∑ Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

## Technological Characteristics Compared to Predicate Device

All technical characteristics are identical to the Predicate Device. The P.F.C.® ∑ Sigma Knee System (Stabilized Plus) is identical to the Predicate device except we are introducing the Stabilized Plus tibial insert components.

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