# Fx Shoulder Solutions Inc. (specification developer, Addison, TX): 4 new FDA device listings, incl. shoulder prosthesis, reverse configuration

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Fx Shoulder Solutions Inc. |
| Owner / operator | FX Shoulder Solutions |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Addison, TX, US |
| New listings | 4 |
| Devices | Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Product codes | PHX, PKC, KWT, HSD |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | FX V135 Easytech |
| First new listing | 2026-05-14 |
| Latest new listing | 2026-05-14 |
| FDA registration number | 3014128390 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.