MetaMedical™ Solutions Inc

FX Shoulder obtains US FDA 510(k) clearance for glenoid baseplates

FX Shoulder Solutions has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its full-wedge augmented glenoid baseplates.

The newly cleared baseplates expand the company’s portfolio with six additional options.

This development introduces a total of 18 glenoid baseplate variations to the market, enhancing surgical flexibility in addressing shoulder conditions.

The glenoid baseplates offer full-wedge options at 7.5° and 15° angles, with lateralisation choices of 0mm, +3mm, or +6mm.

These baseplates are designed with four peripheral screw holes, featuring 12° of polyaxial variability, and can be secured with 4.5mm standard or locking screws.

Surgeons also have the option to employ a 4.5mm central screw through the central post for reinforced fixation, with seven length options ranging from 8-20mm in 2mm increments.

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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.”

In 2022, the FDA issued 510k approval for FX Solutions’ new FX V135 shoulder arthroplasty platform, a 70mm humeral stem that is proximally coated with hydroxyapatite (HAP).

It features suture holes proximally for soft tissue repair, as well as titanium nitride (TiN) coated and uncoated cobalt chrome (CoCr) humeral heads and glenospheres.

Additional features of the platform include unique net-shape moulded humeral cups and 12 different baseplate options in the reverse construct.

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