# Ortoma AB

- Location (FDA's records): Gothenburg, SE
- FDA decisions: 4 (2018–2026): 4 510(k) clearances
- Product codes: OLO (4)
- 510(k) review time since 2016: median 117 days, against 103 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)

## Its most-cited devices
- K232140: OTS Hip (2024), cited by 1
- K181449: Ortoma Treatment Solution - OTS (2018), cited by 1
- K250086: OTS Hip (2025), cited by 1

## Recent decisions
- K261852: OTS Hip (Jul 1, 2026)
- K250086: OTS Hip (May 16, 2025)
- K232140: OTS Hip (Mar 11, 2024)
- K181449: Ortoma Treatment Solution - OTS (Sep 19, 2018)

Source page: https://510kreport.com/company/ortoma