US-based medical equipment manufacturer FX Shoulder Solutions has received the US Food and Drug Administration (FDA) 510k approval for its full-wedge augmented glenoid baseplates.
In 2021, the US regulator approved the company’s lateralised and augmented glenoid baseplates, which added ten additional glenoid baseplate options to the market.
The baseplates were offered in 24mm options with additional lateralisation, augments, and lateralised augments, along with a central screw or central post option.
The FDA approval of full-wedge augmented glenoid baseplates will add six new options to the previously approved portfolio.
It brings the total number of glenoid baseplate options in the market to 18.
FX Shoulder Solutions CEO Baptiste Martin said: “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.”
According to FX Shoulder, augmented glenoid baseplates have become a major solution for surgeons to treat bone loss, defects, or complicated morphologies of the glenoid.
All the glenoid baseplates are offered with 24mm diameter, and full-wedge options at 7.5° and 15° that have options to lateralise 0, +3, or +6mm.
Each glenoid baseplate comes with four peripheral screw holes that bear 12° of polyaxial variability, which can be fixed with 4.5mm standard or locking screws.
The 4.5mm central screw option can be used through the central post for additional fixation comprising seven central screw length options from 8-20mm in 2mm increments.
Also, all glenoid baseplates are made from titanium (Ti6AV) and have a hydroxyapatite coating (CP Ti/HAP), said the medical equipment manufacturer.
