FX Shoulder Solutions

Addison, Texas – November 06, 2026 -- FX Shoulder Solutions has received FDA 510(k) clearance for Easytech Reversed, which the company describes as the first and only stemless reverse shoulder arthroplasty system cleared in the United States. The clearance follows nearly eight years of US clinical investigation.

Seven-site IDE study enrolled 90 patients

FX started the US Investigational Device Exemption (IDE) study in 2018. The multicenter investigation ran across seven sites and covered 90 patients. Follow-up was completed in 2023 and supports the regulatory submission, according to the company. FX also cites more than a decade of international clinical experience with its Easytech technology.

Addison, Texas – November 03, 2026 -- FX Shoulder Solutions has secured certification under the European Union Medical Device Regulation (EU MDR 2017/745) for its Humelock Reversed Shoulder System, the first step in a plan to harmonize its product portfolio across international markets.

The company says the certification supports continued availability of the device in EU markets. Humelock Reversed is the legacy device to the FX V135 Humelock.

PMCF data show a 2.17% overall revision rate at three years

The company cites post-market clinical follow-up (PMCF) data from a cohort of 138 patients with at least three years of follow-up: