section_subject: "Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis."
cfr_reference: "21 CFR 888.3640"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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).
(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.