KXB · Class III — High Risk (PMA approval required, life-sustaining) · Orthopedic · 21 CFR 888.3410
Classification
FDA Product Code
KXB
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 888.3410
Review panel
OR
Medical specialty
Orthopedic
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.