Hintermann Series H3 Total Ankle Replacement System
FDA premarket approval P160036 · decided 2019-06-04
Approval details
- PMA number
- P160036
- Trade name
- Hintermann Series H3 Total Ankle Replacement System
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Dt Medtech, LLC
- Date received
- 2016-08-24
- Decision date
- 2019-06-04
- Days to decision
- 1014 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Towson, MD
- Statement
- Approval for the Hintermann Series H3 Total Ankle Replacement System. The device is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease (e.g. rheumatoid arthritis, hemochromatosis, etc.). The device system is for prescription use.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hintermann Series H2 Total Ankle System (K171004) | Dt Medtech, LLC | 2017-11-07 |