TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 888 - ORTHOPEDIC DEVICES

subpart d - PROSTHETIC DEVICES

888.3540 - Knee joint patellofemoral polymer/metal semi - constrained cemented prosthesis.

  (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (888.3027). The patellar component is designed to be implanted only with its femoral component.

  (b) Classification. Class II. The special controls for this device are: (1) FDA's: (i) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (ii) 510(k) Sterility Review Guidance of 2/12/90 (K901), (iii) Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, (iv) Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices, and (v) Guidance Document for Testing Non-articulating, Mechanically Locked Modular Implant Components, and (2) International Organization for Standardization's (ISO): (i) ISO 58323:1996 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy, (ii) ISO 58324:1996 Implants for SurgeryMetallic MaterialsPart 4: Cobalt-Chromium-Molybdenum Casting Alloy, (iii) ISO 583212:1996 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum Alloy, (iv) ISO 5833:1992 Implants for SurgeryAcrylic Resin Cements, (v) ISO 58342:1998 Implants for SurgeryUltra-high Molecular WeightPolyethylenePart 2: Moulded Forms, (vi) ISO 6018:1987 Orthopaedic ImplantsGeneral Requirements for Marking, Packaging, and Labeling, (vii) ISO 72072:1998 Implants for SurgeryComponents for Partial and Total Knee Joint ProsthesesPart 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials, and (viii) ISO 9001:1994 Quality SystemsModel for Quality Assurance in Design/Development, Production, Installation, and Servicing, and (3) American Society for Testing and Materials': (i) F 7592 Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material, (ii) F 64898 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, (iii) F 79996 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants, (iv) F 104495 Test Method for Shear Testing of Porous Metal Coatings, (v) F 110897 Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants, (vi) F 114795 Test Method for Tension Testing of Porous MetalCoatings, (vii) F 153794 Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants, and (viii) F 167295 Specification for Resurfacing Patellar Prosthesis.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996; 65 FR 17147, Mar. 31, 2000]