CFR

888.3640—Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.

(a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid component made of this alloy or a combination of this alloy and 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 III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any shoulder joint metal/metal or metal/polymer constrained cemented prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a shoulder joint metal/metal or metal/polymer constrained cemented prosthesis that was in commercial distribution before May 28, 1976. Any other shoulder joint metal/metal or metal/polymer constrained cemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Code of Federal Regulations

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996]

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