FX Solutions secures FDA 510k approval for FX V135 platform

FX Solutions has received US Food and Drug Administration (FDA) 510k approval for its new FX V135 shoulder arthroplasty platform.

The FX V135 platform is a 70mm humeral stem, which 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.

The platform also includes unique net-shape moulded humeral cups and 12 different baseplate options in the reverse construct.

It comprises a new-to-market mini stem humeral component that can be aligned at 135° for the reverse and anatomical configurations.

The company’s net-shape moulded humeral cups will allow surgeons to perform reverse construct using an asymmetric humeral cup to change the inclination to 145°.

FX Solutions CEO Baptiste Martin said: “The FX V135 was designed to allow surgeons to tailor our system to the patient – rather than the patient to our system.

“Across our portfolio, now, surgeons are able to lateralise or medialise on both the humeral and glenoid side of the procedure.

“The FX V135 has been long awaited, and we are eager to get this rolled out to the market and continue to grow our market share.”

The FX V135 anatomical configuration includes a taper component, which enables 360° of eccentricity.

This provides for a dual eccentricity offering between the humeral head components and taper.

FX stated that it is introducing the humeral head components with variable head heights to provide enhanced flexibility for surgeons to match the anatomy of patients.

Original Article: (https://www.medicaldevice-network.com/news/fx-solutions-fda-510k-fx-v135-platform/ )