Data / Medical devices / United States / Fx Shoulder Solutions Inc.
Fx Shoulder Solutions Inc.: FDA-registered device maker in Addison, TX, United States, 4 510(k) clearances
Fx Shoulder Solutions Inc. is registered with the FDA (registration 3014128390) in Addison, TX, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 1, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014128390
- Address
- 15920 Addison Rd Suite 200, Addison, TX, United States, 75001
- Owner or operator
- FX Shoulder Solutions (10039598)
- Roles
- Specification developer
- First device listed
- June 8, 2022
- Registered through
- 2026
- Brand names listed
- FX V135 Easytech, FX V135 Shoulder Prosthesis, Humeris® 135 Shoulder System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | 2 | Specification developer | accessdata.fda.gov |
| Shoulder Prosthesis, Reverse Configuration | PHX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2026 | K254154 | FX V135 EASYTECH® Shoulder System | PKC | Substantially Equivalent | FX Shoulder Solutions, Inc. | accessdata.fda.gov |
| June 5, 2023 | K223801 | FX V135(TM) Shoulder Prosthesis | PHX | Substantially Equivalent | Fx Shoulder USA, Inc. | accessdata.fda.gov |
| November 7, 2022 | K222936 | Humeris® 135 Shoulder System | PHX | Substantially Equivalent | Fx Shoulder USA, Inc. | accessdata.fda.gov |
| June 7, 2022 | K213117 | FX V135 Shoulder Prosthesis | PHX | Substantially Equivalent | Fx Shoulder USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 8, 2023 | 93729 | Class II | Ongoing | Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: | Centered glenosphere box may contain an eccentric glenosphere. | accessdata.fda.gov |
Compare with other makers
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Updated May 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.