P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)

K961685 · Johnson & Johnson Professionals, Inc. · JWH · Jul 10, 1996 · Orthopedic

Device Facts

• Record ID: K961685
• Device Name: P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The P.F.C.® ∑ Cruciate Retaining 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

Prosthetic knee system replacing natural knee joint; components include asymmetrical femoral component, tibial inserts, all-polyethylene tibiae, tibial trays, and patellae. Used in orthopedic surgery; implanted by surgeons. Device functions as semi-constrained cemented prosthesis to restore joint function and alleviate pain. Benefits include improved mobility and pain reduction for patients with severe structural knee damage.

Clinical Evidence

Bench testing only. Tests included constraint testing, contact area analysis, surface characteristics, interlock testing, lateral stability, fixation testing, and fatigue strength.

Technological Characteristics

Materials: UHMWPE, Titanium, Co-Cr-Mo alloy. Semi-constrained cemented prosthesis. Components: femoral, tibial inserts, all-polyethylene tibiae, tibial trays, patellae. Fixation: PMMA bone cement.

Indications for Use

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

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.® ∑ Cruciate Retaining Knee System

Submission Summary (Full Text)

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K96/685

510(k) Summary

April 26, 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.® ∑ Cruciate Retaining Knee System (Size 1.5)
*Performance Standards*: No performance standards have been developed for this device.

## Predicate Device

P.F.C.® ∑ Cruciate Retaining Knee System

## Description of Device

The P.F.C.® ∑ Cruciate Retaining Knee System (Size 1.5) consists of:

1. Size 1.5 asymmetrical Femoral component, both porous & non-porous coated;
2. Size 1.5 Tibial inserts;
3. Size 1.5 All-Polyethylene Tibiae (APT);
4. Size 1.5 Tibial trays;
5. Size 32mm Oval dome patellae, three and single peg.

The device is a prosthetic device intended to replace the natural knee joint. The device is constructed of UHMWPE, Titanium and Co-Cr-Mo alloy.

## Intended Use

The P.F.C.® ∑ Cruciate Retaining 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.® ∑ Cruciate Retaining Knee System (Size 1.5) is identical to the Predicate device except we are introducing smaller sized components.

## Performance Tests

The following tests were conducted for a determination of substantial equivalence:

- Constraint Testing
- Contact Areas between all Interfacing Components

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Surface Characteristics of Articulating Surfaces
Modified Surface Data Form Testing
Tibial Insert/Tibial Tray Interlock Testing
Lateral Stability of Patellofemoral Joint
Fixation Testing of Patella Component (Tensile & Shear)
Fatigue Strength of the Tibial Component

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