FX has received the FDA’s 510(k) clearance for its FX V135 implant for use in shoulder arthroplasty procedures.

The system, which features a 70 millimeter humeral stem and suture holes for soft tissue repair, includes humeral head components with variable head heights to allow surgeons more flexibility to best match a patient’s anatomy.

The system has molded humeral cups and a mini-stem humeral component that is set at 135 degrees for both anatomical and reverse configurations. The reverse configuration gives surgeons the option to use an asymmetric humeral cup to change the inclination to 145 degrees.

France-based FX has a U.S. headquarters in Dallas, Texas.