# Orthonovis, Inc.

- Location (FDA's records): Palm Coast, FL
- FDA decisions: 5 (2022–2025): 5 510(k) clearances
- Product codes: HRS (3), HWC (1), KTT (1)
- 510(k) review time since 2016: median 34 days, against 90 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 2 (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
- Laura Cattabriga: 2 (https://510kreport.com/company/laura-cattabriga)
- Industrias Medicas Sampedro S.A.S: 2 (https://510kreport.com/company/industrias-medicas-sampedro)
- Vilex, LLC: 1 (https://510kreport.com/company/vilex)
- Internal Fixation Systems, Inc.: 1 (https://510kreport.com/company/internal-fixation-systems)
- Neoortho Produtos Ortopedicos S/A: 1 (https://510kreport.com/company/neoortho-produtos-ortopedicos-s-a)
- Renovis Surgical Technologies, LLC: 1 (https://510kreport.com/company/renovis-surgical-technologies)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Its most-cited devices
- K250055: BPS - Bone Fragment Fixation Plates, Screws and Washers (2025), cited by 1
- K242343: BPS Wrist Fracture System (2024), cited by 1

## Recent decisions
- K252758: Cannulated Screw and Kirschner (K wire) System (Oct 2, 2025)
- K250498: BPS Wrist Fracture System (Mar 17, 2025)
- K250055: BPS - Bone Fragment Fixation Plates, Screws and Washers (Feb 6, 2025)
- K242343: BPS Wrist Fracture System (Oct 4, 2024)
- K213905: ONX Large External Fixation System (Aug 25, 2022)

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