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: REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
• Classification Name: prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
• Generic Name: total hip arthroplasty system
• Applicant: SMITH & NEPHEW, INC.
• PMA Number: P030022
• Supplement Number: S018
• Date Received: 04/29/2011
• Decision Date: 05/26/2011
• Product Code: MRA [ Registered Establishments with MRA ]
• Advisory Committee: Orthopedic
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Use of an alternative manufacturing supplier.