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. |
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Device | Ceramax Ceramic Total Hip System |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46582 |
PMA Number | P070026 |
Supplement Number | S048 |
Date Received | 06/23/2017 |
Decision Date | 07/13/2017 |
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 |
Approval Order Statement Two changes to the SUMMIT and TRI-LOCK BPS hip stems: automation of the turn taper and laser etch operations, and an increase in degrease process capacity from 2 units/cycle to 5 units/cycle. A third change is proposed to the TRI-LOCK BPS hip stems, which will be to implement a new protective guard to be used during the polishing process. |
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