Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
FDA premarket approval P050050/S024 · decided 2023-11-13
Approval details
- PMA number
- P050050
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2022-08-16
- Decision date
- 2023-11-13
- Days to decision
- 454 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- approval for changing the mobile bearing component material of the Scandinavian Total Ankle Replacement System (S.T.A.R.) from ultra-high molecular weight polyethylene to moderately crosslinked Vitamin E blended ultra-high molecular weight polyethylene.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |