# Response Ortho Solutions, LLC

- Location (FDA's records): Boynton Beach, FL
- FDA decisions: 3 (2024–2026): 3 510(k) clearances
- Product codes: KTT (3)
- 510(k) review time since 2016: median 90 days, against 88 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 0 (0 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
- Wishbone Medical, Inc.: 3 (https://510kreport.com/company/wishbone-medical)
- OrthoPediatrics Corp.: 2 (https://510kreport.com/company/orthopediatrics)
- Ebi, L.P.: 1 (https://510kreport.com/company/ebi)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Recent decisions
- K263083: Response Ortho Smart Fixator - Hexapod System (Oct 2, 2026)
- K252625: The Response Ortho Smart Fixator - Hexapod System (Nov 20, 2025)
- K241769: Response Ortho Metaphyseal Hinge Fixator System (Sep 18, 2024)

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