FX Shoulder Solutions has obtained U.S. FDA 510(k) clearance for the FX V135® Easytech Shoulder System, an advanced shoulder replacement platform developed to enhance surgical flexibility and efficiency.
The newly cleared system enables surgeons to start with a stemless implant technique and, if necessary, switch to a short-stem configuration during the operation without requiring additional implant systems or instruments.
This approach is supported by a simplified workflow that uses a single humeral platform and a two-tray instrument set.
Available in both anatomic and reverse shoulder applications, the FX V135® Easytech features a modular design that combines a stemless anchor base with a detachable stem component, allowing surgeons to adapt treatment options while maintaining procedural efficiency.
Building on the existing FX V135® platform, the new system introduces several enhancements aimed at improving surgical precision.
These include centred humeral cup tapers, a new +1 mm humeral cup option and greater flexibility for adjusting soft tissue tension during surgery.
The clearance further expands the company’s shoulder arthroplasty portfolio, which includes stemless, primary, fracture and revision solutions.
It continues to focus on developing shoulder replacement technologies that improve surgical efficiency, support intraoperative adaptability and address individual patient needs.