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:
- Instability revision rate: 0.72% (1 of 138 patients)
- Device-related revision rate: 1.45% (2 of 138 patients)
- Overall revision rate: 2.17% (3 of 138 patients)
- No reported implant migration or subsidence
FX plans to align its global portfolio in stages
FX intends to progressively align its global portfolio. The plan includes revised surgical instrumentation and additional implant options, subject to applicable regulatory requirements. The company did not disclose timelines, target markets or financial figures for the rollout.
CEO Baptiste Martin called the certification "the first step toward a more unified FX portfolio across international markets." He said the company's focus is on giving surgeons worldwide comprehensive solutions backed by clinical evidence, surgical flexibility and efficient instrumentation, rather than simply adding products.
Portfolio spans stemless to revision procedures
FX Shoulder Solutions, which focuses exclusively on shoulder arthroplasty, offers systems for stemless reconstruction, primary arthroplasty, complex fractures and revision procedures. Its portfolio builds on interlocking humeral stems, intraoperative flexibility and streamlined instrumentation.