Hintermann Series H3 Total Ankle Replacement System
FDA premarket approval P160036/S005 · decided 2024-09-20
Approval details
- PMA number
- P160036
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Hintermann Series H3 Total Ankle Replacement System
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Dt Medtech, LLC
- Date received
- 2023-09-19
- Decision date
- 2024-09-20
- Days to decision
- 367 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Towson, MD
- Statement
- The second post-approval study (PAS002, Hintermann Series H3 TAR Performance Study) is designed to evaluate the trend in performance between each implant size and assess the outcomes of the primary surgeon of the study (accounting for approximately 80% of the registry) compared to other surgeons that are less familiar with the device. You agree to use a prospective, multicenter, single arm post approval study with data supplementation from the UK National Joint Registry (UK NJR)to evaluate the p
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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 |