FX Shoulder Solutions, Inc. · Class II · Cleared May 1, 2026
| K-number | K254154 |
| Device name | FX V135 EASYTECH® Shoulder System |
| Applicant | FX Shoulder Solutions, Inc. |
| Product code | PKC |
| Device class | Class II |
| Decision date | May 1, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3660 |
The FX V135 EASYTECH® Shoulder System is a shoulder replacement prosthesis used for total shoulder arthroplasty in both anatomic and reverse shoulder configurations. It treats severely painful and/or disabled joints from osteoarthritis, rheumatoid arthritis, or massive non-repairable rotator cuff tears. The system features a stemless humeral anchor base that can optionally accommodate a short humeral stem for added support.
The device comprises a Ti6Al4V ELI alloy humeral anchor base and short stem (conforming to ISO 5832-3) paired with pre-assembled UHMWPE humeral cups (ISO 5834-2). It offers intraoperative flexibility to convert from stemless to stemmed configuration without changing the main shoulder component. The coating is identical to the reference predicate device.
ISO 5832-3 (titanium alloy), ISO 5834-2 (UHMWPE), ISO 13485 (Quality Management System). Non-clinical testing included range of motion analysis and construct fatigue testing to verify taper connection integrity and performance.
The FX V135 EASYTECH® is substantially equivalent because it has identical indications for use, comprises the same materials and similar design features as the primary predicate (FX V135® Shoulder Prosthesis K213117), is sterile and gamma-irradiated for single use, and conforms to recognized performance standards. Non-clinical testing demonstrated comparable performance with no new safety or effectiveness questions raised by design differences.
View the full FDA submission: accessdata.fda.gov