Birmingham Hip Resurfacing (BHR) System

FDA premarket approval P040033 · Prosthesis, hip, semi-constrained, metal/metal, resurfacing

PMA numberP040033

Approval

Applicant
Smith & Nephew, Inc.
Received
July 19, 2004
Decision date
May 9, 2006 (APPR)
Supplements
36, latest January 10, 2025
Product code
NXT – Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Official FDA PMA record

Approval order statement

APPROVAL FOR THE BIRMINGHAM HIP RESURFACING (BHR) SYSTEM. THE BHR SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD COMPONENT AND CEMENTLESS ACETABULAR COMPONENT. THE HGR SYSTEM IS INTENDED FOR USE IN PATIENTS REQUIRING PRIMARY HIP RESURFACING ARTHROPLASTY DUE TO: 1) NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, AVASCULAR NECROSIS, OR DYSPLASIA/DEVELOPMENTAL DISLOCATION OF THE HIP (DDH), OR 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS. THE BHR SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING FUTURE IPSILATERAL HIP JOINT REVISION.