Scandinavian Total Ankle Replacment (STAR Ankle)
FDA premarket approval P050050/S016 · decided 2021-01-13
Approval details
- PMA number
- P050050
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Scandinavian Total Ankle Replacment (STAR Ankle)
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2020-12-14
- Decision date
- 2021-01-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Replace a broken coordinate measuring machine (CMM) used in the production of the STAR Tibial, Talar, and UHMWPE Mobile Bearing (also referred to as the Sliding Cores) components with another CMM (Zeiss Contura CMM) at the Waldemar Link contract manufacturing facility in Germany.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |