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 | REFLECTION CERAMIC ACETABULAR SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
PMA Number | P030022 |
Supplement Number | S001 |
Date Received | 09/02/2005 |
Decision Date | 11/17/2005 |
Withdrawal Date
|
08/31/2022 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE ANTHOLOGY HIP STEM FOR USE WITH THE PREVIOUSLY APPROVED REFLECTION CERAMIC ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR USE IN PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, OR TRAUMATIC ARTHRITIS. |
Post-Approval Study | Show Report Schedule and Study Progress |
|
|