FX Shoulder Solutions, Inc. Receives FDA 510k Clearance for Full-Wedge Augmented Glenoid Baseplates

May 16, 2024
8:28 am

ADDISON, Texas , May 16, 2024 /PRNewswire/ -- FX received 510k clearance for its full-wedge augmented glenoid baseplates. The newly cleared baseplates bring 6 new options to the previously cleared portfolio. There are now a combined total of 18 glenoid baseplate options to the market to address a variety of surgeon needs. Augmented glenoid baseplate options have continued to become a growing solution for surgeons to address bone loss, defects, or complicated morphologies of the glenoid.

The glenoid baseplates are all 24mm in diameter with full-wedge options at 7.5° and 15° that have options to lateralize 0, +3, or +6mm. Each glenoid baseplate has four peripheral screw holes that have 12° of polyaxial variability that can be fixed with 4.5mm standard or locking screws. The option to use a 4.5mm central screw can be utilized through the central post for additional fixation (7 central screw length options from 8-20mm in 2mm increments). All glenoid baseplates are made from titanium (Ti6AV) and have a hydroxyapatite coating (CP Ti/HAP).

“This clearance of the full-wedge augmented baseplates further solidifies our portfolio as one of the most comprehensive and innovative shoulder arthroplasty platforms on the market,” said Baptiste Martin, CEO of FX Shoulder Solutions.

FX Shoulder Solutions, Inc. Receives FDA 510k Clearance for Full-Wedge Augmented Glenoid Baseplates

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