The hintermann series h3 total ankle replacement system 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.
| Device | Hintermann Series H3 Total Ankle Replacement System |
| Classification Name | Prosthesis, Ankle, Uncemented, Non-constrained |
| Generic Name | Prosthesis, Ankle, Uncemented, Non-constrained |
| Applicant | DT MedTech LLC |
| Date Received | 2016-08-24 |
| Decision Date | 2019-06-04 |
| PMA | P160036 |
| Supplement | S |
| Product Code | NTG |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DT MedTech LLC 110 West Road suite 227 towson, MA 21204 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160036 | Original Filing | |
| S003 | 2021-09-10 | Normal 180 Day Track No User Fee |
| S002 | 2021-02-26 | 30-day Notice |
| S001 | 2019-07-01 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| B095300205 | P160036 | 000 |
| B095302203 | P160036 | 000 |
| B095302204 | P160036 | 000 |
| B095302205 | P160036 | 000 |
| B095302206 | P160036 | 000 |
| B0953300105 | P160036 | 000 |
| B0953300106 | P160036 | 000 |
| B0953300107 | P160036 | 000 |
| B0953300109 | P160036 | 000 |
| B0953300205 | P160036 | 000 |
| B0953300206 | P160036 | 000 |
| B0953300207 | P160036 | 000 |
| B0953300209 | P160036 | 000 |
| B0953300305 | P160036 | 000 |
| B0953300306 | P160036 | 000 |
| B0953300307 | P160036 | 000 |
| B0953300309 | P160036 | 000 |
| B0953300405 | P160036 | 000 |
| B095302202 | P160036 | 000 |
| B095302201 | P160036 | 000 |
| B095300206 | P160036 | 000 |
| B095300207 | P160036 | 000 |
| B095300305 | P160036 | 000 |
| B095300306 | P160036 | 000 |
| B095300307 | P160036 | 000 |
| B095300309 | P160036 | 000 |
| B095300406 | P160036 | 000 |
| B095300407 | P160036 | 000 |
| B095300409 | P160036 | 000 |
| B095300505 | P160036 | 000 |
| B095300506 | P160036 | 000 |
| B095300507 | P160036 | 000 |
| B095300509 | P160036 | 000 |
| B095300605 | P160036 | 000 |
| B095300606 | P160036 | 000 |
| B095300607 | P160036 | 000 |
| B095300609 | P160036 | 000 |
| B0953300406 | P160036 | 000 |
| B0953300407 | P160036 | 000 |
| B0953301125 | P160036 | 000 |
| B0953302111 | P160036 | 000 |
| B0953302112 | P160036 | 000 |
| B0953302113 | P160036 | 000 |
| B0953302114 | P160036 | 000 |
| B0953302115 | P160036 | 000 |
| B0953302116 | P160036 | 000 |
| B0953302121 | P160036 | 000 |
| B0953302122 | P160036 | 000 |
| B0953302123 | P160036 | 000 |
| B0953302124 | P160036 | 000 |
| B0953302125 | P160036 | 000 |
| B0953302201 | P160036 | 000 |
| B0953302202 | P160036 | 000 |
| B0953302203 | P160036 | 000 |
| B0953302204 | P160036 | 000 |
| B0953302205 | P160036 | 000 |
| B0953301124 | P160036 | 000 |
| B0953301123 | P160036 | 000 |
| B0953300409 | P160036 | 000 |
| B0953300505 | P160036 | 000 |
| B0953300506 | P160036 | 000 |
| B0953300507 | P160036 | 000 |
| B0953300509 | P160036 | 000 |
| B0953300605 | P160036 | 000 |
| B0953300606 | P160036 | 000 |
| B0953300607 | P160036 | 000 |
| B0953300609 | P160036 | 000 |
| B0953301111 | P160036 | 000 |
| B0953301112 | P160036 | 000 |
| B0953301113 | P160036 | 000 |
| B0953301114 | P160036 | 000 |
| B0953301115 | P160036 | 000 |
| B0953301116 | P160036 | 000 |
| B0953301121 | P160036 | 000 |
| B0953301122 | P160036 | 000 |
| B0953302206 | P160036 | 000 |