FX V135 Shoulder Replacement Platform Earns FDA Nod

FX has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its new FX V135 platform, which includes a mini stem humeral component set at 135 degrees for anatomical and reverse configurations.
 
The unique-to-market net shape molded humeral cups lets surgeons use an asymmetric humeral cup if they prefer to change inclination to 145 degrees through the humeral cup. FX V135’s configuration also features a taper component for 360 degrees of eccentricity, allowing dual eccentricity between the taper and humeral head components.
 
The company is launching humeral heads with variable head heights to accommodate patient anatomies.
 
The 70mm humeral stem is coated with hydroxyapatite with proximal suture holes for soft tissue repair, titanium nitride coated and uncoated cobalt chrome humeral heads and glenospheres, and 12 different baseplate options in the reverse construct.
 
“The FX V135 was designed to allow surgeons to tailor our system to the patient—rather than the patient to our system,” Baptiste Martin, CEO of FX told the press. “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.”