P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM

K954481 · Johnson & Johnson Professionals, Inc. · HRY · Oct 10, 1996 · Orthopedic

Device Facts

• Record ID: K954481
• Device Name: P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: Oct 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The P.F.C.* ∑ Uni-compartmental Knee System is indicated for use as a uni-compartmental knee replacement for patients suffering from severe pain and disability due to structural damage caused by advanced femoral-tibial uni-compartmental degenerative arthritis resulting from primary osteoarthritis or trauma. The device is also indicated for use in patients with osteochondritis dissecans of the femoral or tibial condyle. The system is indicated for use only with bone cement.

Device Story

Uni-compartmental knee replacement system; replaces damaged femoral-tibial joint surfaces. Components: cobalt-chromium-molybdenum femoral component; all-plastic UHMWPE tibial component or modular titanium-6 aluminum-4 vanadium tray with UHMWPE insert. Used in orthopedic surgery; implanted by surgeons to restore joint function and alleviate pain in patients with degenerative arthritis or osteochondritis dissecans. Fixation achieved via bone cement. Design modifications from predicate include addition of undercuts on fixation pegs, removal of longitudinal fixation peg channels, and altered A/P topography and chamfering on tibial components to adjust condylar conformity.

Clinical Evidence

Bench testing only. Performance testing included surface finish analysis, tibial insert and tray interlock testing, femoral-tibial contact area analysis, and contact stress calculation.

Technological Characteristics

Materials: Cobalt-chromium-molybdenum alloy (femoral), UHMWPE (tibial), Titanium-6 aluminum-4 vanadium alloy (modular tray). All materials conform to ASTM standards. Semi-constrained, cemented prosthesis. Design features: fixation pegs with undercuts, modular or all-plastic tibial options.

Indications for Use

Indicated for patients with severe pain/disability due to structural damage from advanced femoral-tibial uni-compartmental degenerative arthritis (primary osteoarthritis or trauma) or osteochondritis dissecans of the femoral or tibial condyle. Requires use with bone cement.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• P.F.C.* Uni-compartmental Knee System (K954481)

Submission Summary (Full Text)

{0}

OCT 10 1996
K954481
EXHIBIT 1

# 510(k) SUMMARY

P.F.C.* ∑ Uni-compartmental Knee System

Johnson and Johnson Professional, Inc.
325 Paramount Drive
Raynham, Massachusetts 02767

## 1. Contact Person

Anne M. Griffin, Associate Regulatory Affairs Specialist, (508) 828 - 3107.

## 2. Name of Device

Proprietary Name: P.F.C.* ∑ Uni-Compartmental Knee System
Common Name: Unicompartmental Knee Prosthesis
Classification Name: Knee joint Femorotibial metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II by 21 CFR §888.3530

## 3. Device Classification

Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis has been placed into Class II by FDA (21 CFR §888.3530).

## 4. Substantial Equivalence

The P.F.C.* ∑ Uni-Compartmental Knee System is substantially equivalent in design, materials and principle of operation to the P.F.C.* Uni-compartmental Knee System currently marketed by Johnson and Johnson Professional, Inc. The test data indicate that the modified device, the P.F.C.* ∑ Knee system, is substantially equivalent to the predicate device. The materials used conform to ASTM standards.

## 5. Indications for Use

The P.F.C.* ∑ Uni-compartmental Knee System is indicated for use as a uni-compartmental knee replacement for patients suffering from severe pain and disability due to structural damage caused by advanced femoral-tibial uni-compartmental degenerative arthritis resulting from primary osteoarthritis or trauma. The device is also indicated for use in patients with osteochondritis dissecans of the femoral or tibial condyle. The system is indicated for use only with bone cement.

(1)

{1}

000012

# 6. Physical Description

The P.F.C.* $\sum$ Uni-compartmental Knee System is a uni-compartmental knee replacement consisting of a femoral component of cobalt-chromium-molybdenum alloy, and either an all-plastic tibial component of ultra-high molecular weight polyethylene, or an alternative modular tibial component comprised of a titanium-6 aluminum-4 vanadium alloy tray with a modular UHMWPE insert.

# 7. Technological Characteristics as compared to Predicate Device

A Table of Similarities and Differences is attached as Table I.

The two devices utilize the same materials. All materials conform to ASTM standards.

# 8. Performance Testing

The following testing was carried out for a determination of substantial equivalence:

- Surface Finish Analysis
- Tibial Insert and Tibial Tray Interlock Testing
- Femoral-Tibial Contact Area Analysis
- Contact Stress Calculation

{2}

# TABLE I OF EXHIBIT I

# TABLE OF SIMILARITIES AND DIFFERENCES

Similarities and Differences Table for Femoral component

| | Min. fixation peg cross-sectional area | Undercut on fixation pegs | Longitudinal fixation peg channels | Condylar geometry |
| --- | --- | --- | --- | --- |
| P.F.C. Uni-system(predicate device) | Same | No | Yes | Same |
| P.F.C. ∑ Uni-system | Same | Yes | No | Same |

Similarities and Differences Table for Insert and All UHMWPE Components

| | Assembly mechanism: Insert into tray | Minimum 6 mm UHMWPE thickness | M/L topography | A/P topography | Chamfer |
| --- | --- | --- | --- | --- | --- |
| P.F.C. Uni-system (predicate device) | Same | Yes | Same | More conform-ing | On Anterior portion |
| P.F.C. ∑ Uni-system | Same | Yes | Same | Less conform-ing | On Posterior and Anterior portions |

000013