# Orthoxel

- Location (FDA's records): Bishopstown, IE
- FDA decisions: 2 (2017–2018): 2 510(k) clearances
- Product codes: HSB (2)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 1 (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
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Biomet Manufacturing Corp: 1 (https://510kreport.com/company/biomet-manufacturing)
- I.T.S. GmbH: 1 (https://510kreport.com/company/its)

## Firms that cite its devices most
- Satori Orthopaedics, Inc.: 1 (https://510kreport.com/company/satori-orthopaedics)

## Its most-cited devices
- K170972: Apex Tibial Nailing System (2017), cited by 1

## Recent decisions
- K181375: Apex Femoral Nailing System (Jul 17, 2018)
- K170972: Apex Tibial Nailing System (Dec 20, 2017)

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