Healthcare Industry News:  Hydroxyapatite 

Devices Orthopaedic FDA

 News Release - June 8, 2022

FX Receives 510k Clearance for FX V135(R) Shoulder Arthroplasty Platform

The FX V135® is an Anatomical or Reverse Construct with Options at 135° or 145°

DALLAS, June 8, 2022 -- (Healthcare Sales & Marketing Network) -- FX received 510k approval for their new FX V135® platform which includes a new-to-market mini stem humeral component that is set at 135° for both the anatomical and reverse configurations. With FX's unique-to-market net shape molded humeral cups, the reverse construct also allows surgeons the option to use an asymmetric humeral cup to change the inclination to 145° through the humeral cup component.

The FX V135® anatomical configuration features a taper component that will allow for 360° of eccentricity providing for a dual eccentricity offering between the taper and the humeral head components. New with this system, FX is launching humeral head components with variable head heights to allow surgeons more flexibility to best match the patients' anatomy.

"The FX V135® was designed to allow surgeons to tailor our system to the patient—rather than the patient to our system," said, Baptiste Martin, CEO of FX. "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® is a 70mm humeral stem that is proximally coated with Hydroxyapatite (HAP) featuring suture holes proximally for soft tissue repair, unique-to-market net shape molded humeral cups, Titanium Nitride (TiN) coated and uncoated Cobalt Chrome (CoCr) humeral heads and glenospheres, and (12) different baseplate options in the reverse construct. The humeral stem inclination is at 135° for the anatomical construct and 135° or 145° for the reverse construct.

FX has a US Headquarters in Dallas, Texas and a Global Headquarters in Viriat, France.

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Source: FX Solutions

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