Additive Orthopaedics Receives FDA Clearance for 3D-Printed Osteotomy Wedge System

By Julie A. Vetalice

Additive Orthopaedics received FDA 510(k) clearance for its 3D-printed osteotomy wedge to treat bone fractures or osteotomies in the foot and ankle.

This represents the company's second FDA clearance, following a 3D-printed titanium digital fusion implant announced in 2Q16.

Sources: Additive Orthopaedics, LLC; ORTHOWORLD Inc.

Product Labels: Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory