# Onefit Medical

- Location (FDA's records): Besançon, FR
- FDA decisions: 5 (2014–2018): 5 510(k) clearances
- Product codes: LLZ (5)
- 510(k) review time since 2016: median 71 days, against 90 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 6 (2 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
- Orthocrat, Ltd.: 2 (https://510kreport.com/company/orthocrat)
- Nemaris, Inc.: 1 (https://510kreport.com/company/nemaris)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- Blue Belt Technologies, Inc.: 1 (https://510kreport.com/company/blue-belt-technologies)
- Eos Imaging: 1 (https://510kreport.com/company/eos-imaging)
- Orthosoft Inc (D/B/A Zimmer Cas): 1 (https://510kreport.com/company/orthosoft-d-b-a-zimmer-cas)
- Corin USA: 1 (https://510kreport.com/company/corin-usa)

## Its most-cited devices
- K173390: hipEOS (2018), cited by 2
- K161828: kneeEOS (2016), cited by 1
- K161479: hipEOS (2016), cited by 1
- K160407: spineEOS (2016), cited by 1
- K142671: Onefit Hip Planner (2014), cited by 1

## Recent decisions
- K173390: hipEOS (Apr 27, 2018)
- K161828: kneeEOS (Oct 3, 2016)
- K161479: hipEOS (Jun 28, 2016)
- K160407: spineEOS (Apr 8, 2016)
- K142671: Onefit Hip Planner (Dec 5, 2014)

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