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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, hip, pelvifemoral resurfacing, metal/polymer
Regulation Description Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
Definition Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976.Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis must have an approved pma or a declared completed pdp in effect before being placed in commercial distribution.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKXB
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type PMA
Regulation Number 888.3410
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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