(a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (Sec. 888.3027).
(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 Devices--Part I: Evaluation and Testing,' ''
(ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
(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)) Application for Orthopedic Devices,'' and
(v) ``Guidance Document for Testing Non-articulating, `Mechanically Locked' Modular Implant Components,''
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
(ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
(iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
(iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
(v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular Weight Polyethylene--Part 2: Moulded Forms,''
(vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for Marking, Packaging, and Labeling,'' and
(vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,'' and
(3) American Society for Testing and Materials':
(i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,''
(ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,''
(iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,''
(iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal Coatings,''
(v) F 1108-97 ``Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,''
(vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal Coatings,''
(vii) F 1378-97 ``Specification for Shoulder Prosthesis,'' and
(viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.'' [52 FR 33702, Sept. 4, 1987, as amended at 65 FR 17148, Mar. 31, 2000]