FX Solutions receives FDA 510(k) clearance for shoulder arthroplasty system
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FX Solutions has announced FDA 510(k) clearance of its FX V135 platform for use in anatomic or reverse shoulder arthroplasty, according to a press release.
The FX V135 platform has options at 135° or 145° and features a 70-mm hydroxyapatite-coated humeral stem with proximal suture holes for soft tissue repair. According to the release, the FX V135 platform can be used with an asymmetric humeral cup to change the inclination to 145° for 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 Solutions, said in the release. “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,” Martin added.
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