510(k) Report

FDA applicant

Dt Medtech, LLC

Towson, MD2 decisions2017–20191 recall

FDA records 2 decisions for Dt Medtech, LLC (Towson, MD) from 2017 to 2019: 1 510(k) clearance and 1 original PMA approval. Most are in product codes HSN (Prosthesis, Ankle, Semi-Constrained, Cemented…) and NTG (Prosthesis, Ankle, Uncemented, Non-Constrained). Its devices cite 10 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Dt Medtech, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2017: 12019: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2017high 1 (2026) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Dt Medtech, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1decision
  • NTGProsthesis, Ankle, Uncemented, Non-Constrained1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 20172cite it

What has FDA decided for it lately?

  • P160036Hintermann Series H3 Total Ankle Replacement SystemDt Medtech, LLC · 20191 recall
  • K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017

All 2 as Dt Medtech, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • P160036Hintermann Series Talar Implant, Left, Size 2 REF 302112Mar 24, 2026Class II