KXB

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Product code

KXB

Device name

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Device class

Class 3

21 CFR

21 CFR 888.3410

Medical specialty

Orthopedic

Marketing pathway

PMA

Flag

Implant

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).