# Fx Solutions

- Location (FDA's records): Viriat, FR
- FDA decisions: 8 (2011–2017): 8 510(k) clearances
- Product codes: PHX (3), HSD (2), KWT (2), HRS (1)
- Predicates its devices cite: 23 (9 its own); citations of its devices by later devices: 30 (9 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tornier, Inc.: 5 (https://510kreport.com/company/tornier)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Acu Med, Inc.: 2 (https://510kreport.com/company/acu-med)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Internal Fixation Systems, Inc.: 1 (https://510kreport.com/company/internal-fixation-systems)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)

## Firms that cite its devices most
- Fx Shoulder USA, Inc.: 17 (https://510kreport.com/company/fx-shoulder-usa)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Implantcast GmbH: 1 (https://510kreport.com/company/implantcast)
- Catalyst Orthoscience, Inc.: 1 (https://510kreport.com/company/catalyst-orthoscience)
- FH Industrie: 1 (https://510kreport.com/company/fh-industrie)

## Its most-cited devices
- K163669: Humeris Shoulder (2017), cited by 8
- K150488: Humelock II Reversible Shoulder System (2015), cited by 7
- K162455: Humelock Reversed Shoulder (2017), cited by 6
- K123814: Humelock II Cemented Shoulder System (2013), cited by 4
- K111097: Humelock Cemented Shoulder Prosthesis (2011), cited by 2
- K130759: Humelock II Cementless Shoulder System (2013), cited by 2

## Recent decisions
- K163669: Humeris Shoulder (May 17, 2017)
- K162455: Humelock Reversed Shoulder (Jan 17, 2017)
- K150488: Humelock II Reversible Shoulder System (Nov 13, 2015)
- K143721: PRCT2 (Aug 27, 2015)
- K140071: Humelock II Cemented Shoulder System (Jul 28, 2014)
- K130759: Humelock II Cementless Shoulder System (Nov 9, 2013)
- K123814: Humelock II Cemented Shoulder System (Aug 13, 2013)
- K111097: Humelock Cemented Shoulder Prosthesis (Nov 9, 2011)

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