AmericanHHM
KP - Pentamed® - High performance packaging films for medical devices

FX V135™ Shoulder System Granted 510(k) Clearance for Additional Applications

Friday, June 09, 2023

FX, a leading provider of shoulder solutions, has received FDA clearance to launch their latest innovation in distal interlocking stems. They have introduced new lengths of 120mm, 180mm, and 200mm cementless interlocking stems, complementing their previously cleared 70mm FX V135™ mini. This expansion provides a complete range of sizes for their interlocking humeral stems, offering surgeons intraoperative options to choose between 135° and 145° neck shaft angles in the reverse construct.

The FX V135™ shoulder system stands out in the market with its unique net shape molded humeral cups, allowing surgeons to make last-minute changes to the neck shaft angle even before joint reduction. FX has already established its presence in the US shoulder market with their previously cleared Humelock Reversed® and Humelock II® shoulder systems, supported by published data demonstrating the effectiveness and advantages of their interlocking cementless stems. To access the publications and learn more about FX's offerings, please visit their official website at www.fxshouldersolutions.com.

Baptiste Martin, CEO of FX, expressed excitement about the new additions to their portfolio, stating, "We anticipate these additions will generate a lot of excitement as we bring additional interlocking cementless humeral stems to a complex and challenging corner of the shoulder market. This additional 510(k) clearance is truly a game changer for the shoulder market, providing surgeons with the ability to treat their patients differently."

The 120mm FX V135™ Humelock stem offers surgeons the flexibility to utilize either a 135° or 145° neck shaft angle for primary reverse procedures and 3-4 part fractures using the same stem. This interlocking stem sets itself apart from competitors in the shoulder arthroplasty market.

The introduction of the 180mm and 200mm FX V135™ interlocking humeral long stems marks their debut in the market, expanding the FX portfolio to include cementless stems for complex fractures. These stems also provide a novel shoulder solution in revision settings.

Surgeons using the FX V135™ shoulder system have the ability to trial both the broach and definitive stem at either 135° or 145° neck shaft angles. The newly added FX V135™ stems feature polished suture holes proximally, facilitating soft tissue repair.

FX's glenoid reverse system remains consistent across the portfolio, offering a variety of options including 12 baseplate options and 6 different glenosphere options in sizes 32, 36, and 40mm, available in centered or eccentric styles.

The FX V135™ shoulder system empowers surgeons with a wide range of options, allowing them to create a unique solution tailored to each patient's anatomy rather than conforming the patient to standardized components.

 

Source: prnewswire.com

Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital CongressHealthcare CMO SummitHealthcare CNO Summit