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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR888.3300]
See Related Information on Hip joint metal constrained cemented or uncemented prosthesis. in CDRH databases



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

Sec. 888.3300 Hip joint metal constrained cemented or uncemented prosthesis.

(a)Identification. A hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip 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 components made of alloys, such as cobalt-chromium-molybdenum, and is intended for use with or without bone cement (888.3027). This device is not intended for biological fixation.

(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 hip joint metal constrained cemented or uncemented 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 hip joint metal constrained cemented or uncemented prosthesis that was in commercial distribution before May 28, 1976. Any other hip joint metal constrained cemented or uncemented 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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