DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)

K961379 · Depuy, Inc. · JWH · Jun 18, 1996 · Orthopedic

Device Facts

• Record ID: K961379
• Device Name: DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)
• Applicant: Depuy, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The DePuy AMK Porous Coated CRX Tibial Tray is intended to be used as the tibial component in cemented total knee arthroplasty.

Device Story

Cast cobalt chrome (Co-Cr-Mo) tibial tray; fixed, tapered, cylindrical central stem; two posterior fins; porous coating on undersurface; optional screw holes. Used as tibial component in cemented total knee arthroplasty. Implanted by orthopedic surgeons in clinical/OR settings. Provides structural support and fixation for knee joint replacement; porous coating facilitates biological fixation; screw holes provide additional mechanical stability options.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use similarities to predicate devices.

Technological Characteristics

Material: Co-Cr-Mo alloy. Design: Cast tibial tray with fixed tapered cylindrical stem and two posterior fins. Features: Porous coating on undersurface, optional screw holes. Sizes: Four standard, five 'plus'.

Indications for Use

Indicated for patients undergoing cemented total knee arthroplasty requiring a tibial component.

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

• Depuy AMK Cemented CRX Tibial Tray
• DePuy Synatomic Variable Fit Tibial Plateau
• Howmedica PCA Modular Stemmed Tibial Baseplate

Submission Summary (Full Text)

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06·12/96 08:32 219 267 7045 REGULATORY&CLIN ---> CDRH ODE 003
JUN 18 1996
K961379

# SUMMARY OF SAFETY AND EFFECTIVENESS

**NAME OF FIRM:** DePuy Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988

**FIRM CONTACT:** Sally Foust
Clinical Research Specialist

**TRADE NAME:** DePuy AMK Porous Coated CRX Tibial Tray

**COMMON NAME:** Knee Prosthesis

**CLASSIFICATION:** 888.3560 Knee joint patellofemorotibial,
polymer/metal/polymer semi-constrained cemented
prosthesis

**DEVICE PRODUCT CODE:** 87 JWH

**SUBSTANTIALLY EQUIVALENT DEVICES:**
Depuy AMK Cemented CRX Tibial Tray
DePuy Synatomic Variable Fit Tibial Plateau
Howmedica PCA Modular Stemmed Tibial Baseplate

## DEVICE DESCRIPTION AND INTENDED USE:

The DePuy AMK Porous Coated CRX Tibial Tray is a cast cobalt chrome tibial tray available
in four standard sizes and five "plus" tibial sizes. The tray has a fixed, tapered, cylindrical
central stem and two posterior fins originating at the central stem, and porous coating on the
undersurface. The DePuy AMK Porous Coated CRX Tibial Tray is intended to be used as the
tibial component in cemented total knee arthroplasty.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy AMK Porous Coated CRX Tibial Tray is identical to the DePuy AMK Cemented
CRX Tibial Tray cleared as the tibial component in cemented total knee arthroplasty except for
the addition of the undersurface porous coating and the option of a tibial tray with screw holes.

Both the DePuy AMK Porous Coated and Cemented CRX Tibial Trays are manufactured from
Co-Cr-Mo alloy and are available in four standard and five "plus" tibial sizes. Both have a
fixed, tapered, cylindrical stem and two posterior fins originating at the central stem. The
intended use (cemented total knee arthroplasty) of the AMK Porous Coated CRX Tibial Tray is
identical to that of the DePuy AMK Cemented CRX Tibial Tray.

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