Sam Brusco, Associate Editor05.16.24
FX Shoulder Solutions has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for six new full-wedge, augmented glenoid baseplates. There are now 18 glenoid baseplates in the company’s portfolio.
The Addison, Texas-based company said all the baseplates are 24 mm in diameter and have full-wedge options at 7.5° and 15° as well as options to lateralize 0, +3, or +6 mm. They have four peripheral screw holes with 12° of polyaxial variability that can be fixed with 4.5 mm standard or locking screws.
The option to use the 4.5 mm central screw can be done through the central post for further fixation with seven central screw length options from 8-20 mm in 2mm increments. All the glenoid baseplates are composed of titanium and have a hydroxyapatite coating.
FX said augmented glenoid baseplate options are a growing solution for surgeons to address bone loss, defects, or complicated morphologies of the glenoid. The company also said it innovates based on feedback from surgeons and market trends, with exclusive focus on shoulder arthroplasty.
"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.
The Addison, Texas-based company said all the baseplates are 24 mm in diameter and have full-wedge options at 7.5° and 15° as well as options to lateralize 0, +3, or +6 mm. They have four peripheral screw holes with 12° of polyaxial variability that can be fixed with 4.5 mm standard or locking screws.
The option to use the 4.5 mm central screw can be done through the central post for further fixation with seven central screw length options from 8-20 mm in 2mm increments. All the glenoid baseplates are composed of titanium and have a hydroxyapatite coating.
FX said augmented glenoid baseplate options are a growing solution for surgeons to address bone loss, defects, or complicated morphologies of the glenoid. The company also said it innovates based on feedback from surgeons and market trends, with exclusive focus on shoulder arthroplasty.
"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.