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: Trident Alumina Insert
• Generic Name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
• Applicant: Howmedica Osteonics Corp.; 325 Corporate Dr.; Mahwah, NJ 07430
• PMA Number: P000013
• Supplement Number: S015
• Date Received: 09/20/2018
• Decision Date: 10/18/2018
• Product Code: MRA
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Change in corrosion protection oil used during the vendor's proof test.