# Akros Medical

- Location (FDA's records): Durham, NC
- FDA decisions: 3 (2017–2020): 3 510(k) clearances
- Product codes: HTN (3)
- 510(k) review time since 2016: median 52 days, against 88 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 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
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)

## Firms that cite its devices most
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)

## Its most-cited devices
- K173550: Akros FibuLink™ Syndesmosis Repair Kit (2017), cited by 1
- K162805: Akros Fibulink Syndesmosis Repair Kit (2017), cited by 1

## Recent decisions
- K200361: Akros Scruture Anchor LisFranc Repair Kit (Apr 6, 2020)
- K173550: Akros FibuLink™ Syndesmosis Repair Kit (Dec 14, 2017)
- K162805: Akros Fibulink Syndesmosis Repair Kit (Jan 10, 2017)

Source page: https://510kreport.com/company/akros-medical