510(k) Report

FDA applicant

Truemed Group, LLC

The Woodlands, TX5 decisions2014–20210 recalls

FDA records 5 decisions for Truemed Group, LLC (The Woodlands, TX) from 2014 to 2021: 5 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 294 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 4 of them its own earlier devices. No 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 Truemed Group, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 12017: 12018: 12019: 12021: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Truemed Group, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone3decisions
  • HSBRod, Fixation, Intramedullary And Accessories2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 294 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 106 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 22 predicates; 4 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC · 20172cite it
  • K133166Ins Hilden Tibial ArzztTruemed Group, LLC · 20141cites it
  • K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC · 20191cites it

What has FDA decided for it lately?

  • K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC · 2021
  • K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC · 2019
  • K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden…Truemed Group, LLC · 2018
  • K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC · 2017
  • K133166Ins Hilden Tibial ArzztTruemed Group, LLC · 2014

All 5 as Truemed Group, LLC →