Dt Medtech, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Dt Medtech, LLC” (first 2017, latest 2017), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 217 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 217 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dt Medtech, LLC took a median 217 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained | 1 | 0 |
Review panels
- Orthopedic (2)
Most recent Dt Medtech, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171004 | Hintermann Series H2 Total Ankle System | HSN | 2017-11-07 | 217 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160036 | PMA | Hintermann Series H3 Total Ankle Replacement System | 2019-06-04 |
Recalls
3 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2026-03-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Dt Medtech, LLC is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT04770870: Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System (Recruiting, started 2022-02-01)
- NCT06514196: Post- Approval Hintermann Series H® Study 1 (Active not recruiting, started 2020-06-18)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dt Medtech, LLC?
FDA lists 1 510(k) clearance under the applicant name “Dt Medtech, LLC” (first 2017, latest 2017), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dt Medtech, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dt Medtech, LLC is 217 days.
Which FDA product codes appear under Dt Medtech, LLC?
The most frequent FDA product codes under this applicant name are HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, 1); NTG (Prosthesis, Ankle, Uncemented, Non-Constrained, 1).
Next steps
- See all 1 Dt Medtech, LLC clearances with predicates and recalls
- Run predicate analysis for product code HSN, Dt Medtech, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.