# Mr Surgical Solutions, LLC

- Location (FDA's records): Conshohocken, PA
- FDA decisions: 3 (2025–2025): 3 510(k) clearances
- Product codes: SBF (3)
- 510(k) review time since 2016: median 30 days, against 90 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: 1 (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
- Pixee Medical: 1 (https://510kreport.com/company/pixee-medical)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Orthosoft Inc (D/B/A Zimmer Cas): 1 (https://510kreport.com/company/orthosoft-d-b-a-zimmer-cas)

## Its most-cited devices
- K250108: OptiVu™ Shoulder (2025), cited by 1

## Recent decisions
- K252530: OptiVu™ Shoulder (Sep 10, 2025)
- K252170: OptiVu™ Shoulder (Aug 8, 2025)
- K250108: OptiVu™ Shoulder (Jul 9, 2025)

Source page: https://510kreport.com/company/mr-surgical-solutions