# Truemed Group, LLC

- Location (FDA's records): The Woodlands, TX
- FDA decisions: 5 (2014–2021): 5 510(k) clearances
- Product codes: HRS (3), HSB (2)
- 510(k) review time since 2016: median 294 days, against 106 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 22 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 13 (https://510kreport.com/company/synthes-usa)
- Depuy Ace: 1 (https://510kreport.com/company/depuy-ace)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Mcginley Innovations: 1 (https://510kreport.com/company/mcginley-innovations)

## Its most-cited devices
- K162507: Arzzt 3.5 / 4.5 Small & Large Fragments System (2017), cited by 2
- K133166: Ins Hilden Tibial Arzzt (2014), cited by 1
- K182650: Arzzt Distal Radius and Ulna System (2019), cited by 1

## Recent decisions
- K200575: Truemed Hand, Foot and Ankle Plates System (Jul 9, 2021)
- K182650: Arzzt Distal Radius and Ulna System (Jun 10, 2019)
- K172189: Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt (Jan 16, 2018)
- K162507: Arzzt 3.5 / 4.5 Small & Large Fragments System (Aug 3, 2017)
- K133166: Ins Hilden Tibial Arzzt (Nov 6, 2014)

Source page: https://510kreport.com/company/truemed-group