Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
• Classification Name: prosthesis, hip, semi-constrained, metal/metal, resurfacing
• Generic Name: total hip resurfacing prosthesis, metal-on-metal
• Applicant: SMITH&NEPHEW ORTHOPAEDICS
• PMA Number: P040033
• Supplement Number: S016
• Date Received: 09/14/2010
• Decision Date: 10/13/2010
• Product Code: NXT [ Registered Establishments with NXT ]
• Advisory Committee: Orthopedic
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for revisions to the physician and patient labeling.