# Fx Shoulder USA, Inc.

- Location (FDA's records): Dallas, TX
- FDA decisions: 11 (2019–2024): 11 510(k) clearances
- Product codes: PHX (9), PKC (1), KWT (1)
- 510(k) review time since 2016: median 145 days, against 143 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 23 (4 its own); citations of its devices by later devices: 8 (4 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
- Fx Solutions: 17 (https://510kreport.com/company/fx-solutions)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Tornier, Inc.: 1 (https://510kreport.com/company/tornier)

## Firms that cite its devices most
- Medacta International S.A.: 2 (https://510kreport.com/company/medacta-international)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)
- FX Shoulder Solutions, Inc.: 1 (https://510kreport.com/company/fx-shoulder-solutions)

## Its most-cited devices
- K213117: FX V135 Shoulder Prosthesis (2022), cited by 3
- K192206: 32mm Glenosphere and Humeral Cup (2019), cited by 1
- K193394: Humeral Cup Stability & Humeral Cup 135/145o Stability (2020), cited by 1
- K192799: Glenoid Baseplate with Screw (2020), cited by 1
- K210790: Lateralized and Augmented Baseplates (2021), cited by 1
- K223801: FX V135(TM) Shoulder Prosthesis (2023), cited by 1

## Recent decisions
- K240278: Full Wedge Lateralized and Augmented Baseplates (May 15, 2024)
- K223801: FX V135(TM) Shoulder Prosthesis (Jun 5, 2023)
- K222936: Humeris® 135 Shoulder System (Nov 7, 2022)
- K213117: FX V135 Shoulder Prosthesis (Jun 7, 2022)
- K210790: Lateralized and Augmented Baseplates (Aug 25, 2021)
- K201391: Easytech® Anatomical Shoulder System (Feb 16, 2021)
- K191698: TiN Coated Humeral Head (Jul 16, 2020)
- K191146: Humelock TiN Coated Glenosphere (Jul 15, 2020)

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