FX Shoulder gets FDA 510(k) clearance for glenoid baseplates

FX Shoulder Solutions has received FDA 510(k) clearance for its full-wedge augmented glenoid baseplates, adding six new options to its portfolio. This expands the total glenoid baseplate variations to 18, offering surgeons more flexibility in treating shoulder conditions.

The newly cleared baseplates include full-wedge options at 7.5° and 15° angles, with lateralisation choices of 0mm, +3mm, or +6mm. They present four peripheral screw holes with 12° of polyaxial variability and can be used with 4.5mm locking or standard screws. Surgeons can also opt for a 4.5mm central screw through the central post for reinforced fixation, available in seven length options from 8-20mm.

These baseplates have proximal suture holes for soft tissue repair and are available with titanium nitride (TiN) coated or uncoated cobalt chrome (CoCr) humeral heads and glenospheres. Additionally, the platform offers unique net-shape moulded humeral cups and 12 different baseplate options in the reverse construct.