Title 21

SECTION 888.3220

888.3220 Finger joint metal/polymer constrained cemented prosthesis.

§ 888.3220 Finger joint metal/polymer constrained cemented prosthesis.

(a) Identification. A finger joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one anatomic plane, and consists of two components which are linked together. This generic type of device includes prostheses that are made of alloys, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene, and 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 finger joint 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 finger joint metal/polymer constrained cemented prosthesis that was in commercial distribution before May 28, 1976. Any other finger joint metal/polymer constrained cemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]

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