FX gets FDA 510k approval for FX V135

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

The FX V135 is a 70mm humeral stem, proximally coated with hydroxyapatite (HAP), and features suture holes proximally for soft tissue repair.

It includes unique net-shape moulded humeral cups, Titanium Nitride (TiN) coated and uncoated Cobalt Chrome (CoCr) humeral heads and glenospheres and 12 different baseplate options in the reverse construct.

FX 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 lateralize or medialize 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 platform comprises a new-to-market mini stem humeral component that can be aligned at 135° for both the anatomical and reverse configurations.

Also, the unique net-shape moulded humeral cups would allow the surgeons to perform a reverse construct using an asymmetric humeral cup to change the inclination to 145°.

The anatomical configuration of FX V135 features a taper component that enables 360° of flexibility and provides dual eccentricity between taper and humeral head components.

FX is offering the humeral head components with variable head heights, to provide surgeons with enhanced flexibility in matching the patients’ anatomy.

In August last year, the company received FDA 510k approval for its lateralized and augmented glenoid baseplates, available with a central screw or central post option.

Earlier this year, FX Solutions merged with its US subsidiary FX Shoulder USA, which is a direct provider of the company’s shoulder replacement devices in the US. NS Medical Devices