Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: STELKAST SURPASS ACETABULAR SYSTEM
• Generic Name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
• Applicant: Stelkast Company; 200 Hidden Valley Rd.; Mcmurray, PA 15317
• PMA Number: P040051
• Supplement Number: S002
• Date Received: 10/06/2009
• Decision Date: 04/22/2011
• Withdrawal Date: 05/12/2016
• Product Code: MRA
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.