# Ortho Solutions UK, Ltd.

- Location (FDA's records): Maldon, GB
- FDA decisions: 5 (2017–2025): 5 510(k) clearances
- Names in FDA's records: Ortho Solutions UK , Ltd. (4); Ortho Solutions UK Limited (1)
- Product codes: HRS (2), JDR (1), HSB (1), HWC (1)
- 510(k) review time since 2016: median 60 days, against 88 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 3 (1 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
- Ortho Solutions Limited: 7 (https://510kreport.com/company/ortho-solutions)
- Vilex, LLC: 2 (https://510kreport.com/company/vilex)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- In2bones Sas: 1 (https://510kreport.com/company/in2bones)
- Ascent Medical, LLC: 1 (https://510kreport.com/company/ascent-medical)
- I.T.S. GmbH: 1 (https://510kreport.com/company/its)

## Firms that cite its devices most
- Auxano Medical, LLC: 1 (https://510kreport.com/company/auxano-medical)
- Brm Extremities: 1 (https://510kreport.com/company/brm-extremities)

## Its most-cited devices
- K163489: OrthoSolutions 'System26' Bone Screws (2017), cited by 2
- K202764: Ortho Solutions Plating System (2020), cited by 1

## Recent decisions
- K250622: Succession™ AFN System (Aug 7, 2025)
- K240212: COGNiTiON™ Staple System (Feb 23, 2024)
- K210658: Volition Plating System (Apr 13, 2021)
- K202764: Ortho Solutions Plating System (Nov 20, 2020)
- K163489: OrthoSolutions 'System26' Bone Screws (Mar 8, 2017)

Source page: https://510kreport.com/company/ortho-solutions-uk