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: SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
• Generic Name: Prosthesis, ankle, uncemented, non-constrained
• Applicant: Djo Global; 9800 Metric Blvd.; Austin, TX 78758
• PMA Number: P050050
• Supplement Number: S004
• Date Received: 09/04/2012
• Decision Date: 05/01/2013
• Product Code: NTG
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZRINSKI AG IN WURMLINGEN, GERMANY.