# Apogee Orthosolutions

- Location (FDA's records): Chesterland, OH
- FDA decisions: 1 (2013–2013): 1 510(k) clearance
- Product codes: HWC (1)
- Predicates its devices cite: 18 (0 its own); citations of its devices by later devices: 6 (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
- Synthes (Usa): 7 (https://510kreport.com/company/synthes-usa)
- Vilex, LLC: 4 (https://510kreport.com/company/vilex)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Osteomed LP: 1 (https://510kreport.com/company/osteomed)
- Orthohelix Surgical Designs, Inc.: 1 (https://510kreport.com/company/orthohelix-surgical-designs)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Pioneer Surgical Technology: 1 (https://510kreport.com/company/pioneer-surgical-technology)

## Firms that cite its devices most
- Paragon 28, Inc.: 2 (https://510kreport.com/company/paragon-28)
- Treace Medical Concepts, Inc.: 1 (https://510kreport.com/company/treace-medical-concepts)
- Vilex, LLC: 1 (https://510kreport.com/company/vilex)
- Azurmeds, Inc.: 1 (https://510kreport.com/company/azurmeds)
- Extremity Medical, LLC: 1 (https://510kreport.com/company/extremity-medical)

## Its most-cited devices
- K124027: Monster Screw System (2013), cited by 6

## Recent decisions
- K124027: Monster Screw System (Apr 5, 2013)

Source page: https://510kreport.com/company/apogee-orthosolutions