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FX Receives 510k Clearance for FX V135® Shoulder Arthroplasty Platform

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

DALLAS, June 8, 2022 /PRNewswire/ — 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.

For further information, please contact info@fxshouldersolutions.com or info@fxshouldersolutions.fr.

US Headquarters
13465 Midway Road, Suite 101
Dallas, TX 75244
Tel 1-800-280-0775
Fax 1-800-429-8965
info@fxshouldersolutions.com

Global Headquarters
1663 rue de Majornas
01449 Viriat – France
Tel +33 4 74 55 35 55
Fax +33 4 74 52 44 01
info@fxshouldersolutions.fr

SOURCE FX Solutions

Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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