Fx Solutions Receives 510k Clearance For Expanded Applications Of Their Innovative Fx V135™ Shoulder System
FX has recently received FDA clearance for its latest innovation, the FX V135™ Shoulder System. This groundbreaking system stands as the first and only interlocking shoulder system with intraoperative options between 135° and 145° for reverse total shoulder arthroplasty. It introduces a range of advancements to the field of shoulder arthroplasty.
With this clearance, FX expands its product portfolio by introducing new lengths of cementless interlocking stems. These additions include the 120mm, 180mm, and 200mm stems, which complement the previously cleared 70mm (non-interlocking) FX V135™ mini. Surgeons using the FX V135™ system gain access to a complete range of interlocking humeral stems, providing intraoperative options for neck shaft angles.
Surgeons utilizing the FX V135™ system can choose between 135° and 145° neck shaft angles, even during the final moments before joint reduction. This flexibility is made possible through the use of FX's unique net shape molded humeral cups. These cups set FX apart from other market players and offer surgeons the ability to customize their approach.
FX has already established itself as a leader in the shoulder market, with previously cleared systems such as the Humelock Reversed® and Humelock II® shoulder systems. These systems have been backed by published data showcasing their efficacy and advantages. The additional clearance for the FX V135™ shoulder system further solidifies the company's commitment to innovation and shoulder arthroplasty.
The FX V135™ system offers surgeons a wide range of options to create tailored solutions that adapt to each patient's anatomy. The ability to choose between different neck shaft angles, simply by changing the one-piece FX humeral component, makes this system unique and highly versatile. FX remains dedicated to shoulder arthroplasty as their sole focus, allowing them to bring significant advancements to the field.
In conclusion, FX's recent 510k clearance for the FX V135™ Shoulder System introduces a new era in interlocking shoulder systems. Surgeons now have access to a comprehensive range of interlocking humeral stems, along with the ability to choose neck shaft angles, ultimately leading to better patient outcomes.