(69 days)
The DcPuy AMK Porous Coated CRX Tibial Tray is intended to be used as the tibial component in cemented total knee arthroplasty.
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 stern, and porous coating on the undersurface.
I am sorry, but the provided text describes a medical device (DePuy AMK Porous Coated CRX Tibial Tray) and its regulatory submission for substantial equivalence. It does not contain any information regarding acceptance criteria or a study related to device performance in an AI or diagnostic context.
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06 12/96 08:32 2219 267 7045
JUN 18 1996
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
DePuy AMK Porous Coated CRX Tibial Tray TRADE NAME:
COMMON NAME:
CLASSIFICATION:
Knee Prosthesis
888.3560 Knee joint patchlofemorotibial, 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 stern, and porous coating on the undersurface. The DcPuy 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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§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.