Vendor/Manufacturer: DePuy Orthopaedics Incorporated
Product/Product Line: ATTUNE® Revision Knee System
Vendor/Manufacturer Catalog #: 1504-40-206
Global Unique Device (GUD) Primary Device Identifier Number: 10603295042297
Global Unique Device (GUD) Device Description:
ATTUNE KNEE SYSTEM REVISION CRS FEMORAL CEMENTED, RIGHT, SIZE 6
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Uncoated knee femur prosthesis, metallic
Global Medical Device Nomenclature (GMDN) Definition:
An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3560
FDA Regulation Description Classification Name:
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
FDA Classification Product Code(s): JWH, MBH, NJL
FDA Classification Product Code Device Name(s):
JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
NJL: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
FDA Premarket Submission(s): K160700
The DePuy ATTUNE® Revision Knee System is SUBSTANTIALLY EQUIVALENT to the following products:
For more information, please visit us at Infonomics.com
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