FX Shoulder Solutions has announced US Food and Drug Administration 510(k) clearance of Easytech Reversed, which the company describes as the first cleared stemless reverse shoulder arthroplasty system in the United States.

The decision follows a development programme that included a US Investigational Device Exemption study initiated in 2018. The investigation enrolled 90 patients across seven centres, with follow-up completed in 2023.

Easytech Reversed provides an alternative to conventional humeral stems. Its peripheral fixation design engages the upper humerus near the cortical bone boundary, avoiding a stem extending into the intramedullary canal. The company identifies this approach as an option for appropriately selected patients, including those with unusual proximal humeral anatomy or a malaligned canal.

The system shares its humeral anchor architecture with FX’s stemless anatomical shoulder implant, available in the United States since 2021.

Peripheral fixation and implant configuration

FX’s international product documentation describes a 145-degree neck-shaft angle and peripheral pegs intended to establish initial fixation. Titanium and hydroxyapatite coatings are designed to support longer-term fixation.

The international configuration includes cementless anchor bases in three sizes, 36 mm and 40 mm glenospheres, and polyethylene humeral cups in multiple heights. These specifications describe the international product range; US component availability should be checked against local labelling.

The clearance extends FX’s portfolio across anatomical and reverse shoulder replacement, fracture reconstruction and revision surgery. Its earlier clinical development announcement positioned the stemless approach as intended to preserve humeral bone compared with conventional stemmed implants.