SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
FDA premarket approval P050050 · decided 2009-05-27
Approval details
- PMA number
- P050050
- Trade name
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2005-12-07
- Decision date
- 2009-05-27
- Days to decision
- 1267 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Austin, TX
- Statement
- APPROVAL FOR THE STAR ANKLE. THE DEVICE IS INDICATED FOR USE AS A NON-CEMENTED IMPLANT TO REPLACE A PAINFUL ARTHRITIC ANKLE JOINT DUE TO OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS OR RHEUMATOID ARTHRITIS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |