Who is the manufacturer of DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)?

Depuy, Inc. filed the 510(k) submission for DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) (K961379).

What is the FDA product code for DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)?

JWH. It is classified under 21 CFR 888.3560 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Q: What are the predicate devices for DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)?

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

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

Intended 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

Related Devices

K983657 — OSTEONICS SERIES 7000 AD TIBIAL TRAY · Osteonics Corp. · Apr 6, 2000
K984158 — P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY · Depuy, Inc. · Jan 28, 1999
K991106 — P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY · DePuy Orthopaedics, Inc. · Jun 9, 1999
K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENT · Encore Orthopedics, Inc. · Jul 6, 2004
K963148 — NEXGEN COMPLETE KNEE SOLUTION · Zimmer, Inc. · Feb 13, 1997

Submission Summary (Full Text)

{0} 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. 600013