Humelock Reversed EU Certification Starts FX Portfolio Alignment

FX Shoulder Solutions announced on November 3, 2026 that its Humelock Reversed Shoulder System has achieved certification under the European Union Medical Device Regulation (EU MDR 2017/745). The certification supports continued availability of the established device and is the first step in an initiative to harmonize the company’s shoulder-arthroplasty portfolio across international markets.

The regulatory milestone matters commercially because it connects compliance with portfolio continuity. Humelock Reversed is the legacy device to the FX V135 Humelock and an established part of FX’s reverse shoulder-arthroplasty range. Rather than announcing a separate dated product launch, the company is using the certification as the foundation for a more consistent international offering.

CEO Baptiste Martin called the achievement “an important milestone in our global strategy,” framing the goal as surgeon access to comprehensive solutions supported by clinical evidence, surgical flexibility and efficient instrumentation rather than simply a larger product count.

That alignment is intended to proceed progressively through revised surgical instrumentation, additional implant options and continued advancements in FX’s shoulder-arthroplasty systems, subject to applicable regulatory requirements. The portfolio spans stemless reconstruction, primary shoulder arthroplasty, complex fractures and revision procedures, making the harmonization program relevant beyond the certified implant line.

Clinical Follow-Up Behind The Platform

FX reported post-market clinical follow-up from 138 patients with at least three years of follow-up. The overall revision rate was 2.17%, representing three patients. Two patients had device-related revisions, a rate of 1.45%, while one had a revision for instability, or 0.72%. No implant migration or subsidence was reported in the cohort.

Those results form the clinical backdrop to the certification announcement. The announcement ties the outcomes to the platform’s established heritage and FX’s focus on implant stability and long-term performance, providing context for retaining Humelock Reversed while the broader portfolio develops.

Device Design And Implant Options

The official Humelock Reversed specifications describe a trauma reverse prosthesis with a 120-millimetre stem originally designed for both primary reverse and trauma applications and a 145-degree neck-shaft angle. Its tulip-shaped stem has proximal plasma-sprayed commercially pure titanium and hydroxyapatite coating, designed to promote cementless long-term fixation.

The configuration range helps explain the emphasis on implant choice and instrumentation. The system offers nine cementless stem sizes spanning 8 to 16 millimetres distally, three proximal body sizes and three glenosphere sizes. Six heights of polyethylene humeral cups provide 54 possible combinations. The cups are thermocompressed polyethylene on a titanium-alloy shell and attach to the stem with a double morse taper intended to eliminate back-table assembly and possible backside wear. Distal interlocking screws ranging from 18 to 36 millimetres are designed to allow intraoperative adjustment of height and version.

The certification’s immediate consequence is continuity for an established implant line, not completion of the international portfolio overhaul. Revised instruments and additional implant options remain future steps under applicable regulatory requirements. FX has established a regulatory foundation for its harmonization strategy; the substantive test is how consistently those changes are carried across its wider shoulder-reconstruction portfolio.