# Arex USA

- Location (FDA's records): Collegeville, PA
- FDA decisions: 3 (2008–2013): 3 510(k) clearances
- Names in FDA's records: Arex USA (2); Arex USA, LLC (1)
- Product codes: HTY (2), HWC (1)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 3 (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
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Smith & Nephew, Inc., Orthopaedic Div.: 1 (https://510kreport.com/company/smith-nephew-orthopaedic-div)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Firms that cite its devices most
- Virak Orthopedic Research, LLC: 1 (https://510kreport.com/company/virak-orthopedic-research)
- Osteocentric Extremities, LLC: 1 (https://510kreport.com/company/osteocentric-extremities)

## Its most-cited devices
- K094043: Ligamentotaxor (2010), cited by 2
- K081011: Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 (2008), cited by 1

## Recent decisions
- K122415: X-Fix Dynamic External Distractor (Mar 15, 2013)
- K094043: Ligamentotaxor (Aug 17, 2010)
- K081011: Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 (Nov 7, 2008)

Source page: https://510kreport.com/company/arex-usa