OrthoXel Gains FDA Clearance, CE Mark Approval for Apex Tibial Nail

By Julie A. Vetalice

OrthoXel received FDA 510(k) clearance and approval under the CE Mark for the Apex Tibial Nailing system.

The device reportedly offers the largest range of locking options of any intramedullary nail, and features a micromotion locking mode to support controlled axial movement with torsional stability for optimal callus formation. The design requires no changes to established evidence-based reamed insertion techniques.

Apex also provides additional locking modes such as standard cross-locking, rigid fixation with multiple proximal screw clamping and dynamization locking with built-in torsional stability.

Source: OrthoXel DAC

OrthoXel Apex Tibial Nailing System

Image courtesy of OrthoXel

Product Labels: Lower Extremity

Tags: 510(k) Clearance, CE Mark, Regulatory