Additive Orthopaedics Gains FDA Clearance of Patient Specific 3D Printed Bone Segments

By Julie A. Vetalice

Additive Orthopaedics received FDA 510(k) clearance to market Patient Specific 3D-Printed Bone Segments for ankle and foot fixation.

Per leadership, the company's lattice structures have shown close to 90% bony ingrowth after 6 months, with no use of biologics.

Over 1,000 of the company's devices have been implanted since commercial launch in early 2017. The company has recently closed a Series B round of US $1.0MM.

Source: Additive Orthopaedics, LLC

Product Labels: Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory