FX Shoulder Wins EU MDR Certification for Humelock Reversed
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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: