Research & Development
Additive Orthopaedics awarded US FDA's clearance for patient specific 3D Printed Bone implants
17 May 2018 -

Orthopaedic device company Additive Orthopaedics LLC revealed on Wednesday that it has passed the US FDA's 510(k) clearance for its Patient Specific 3D Printed Bone Segments to address internal bone fixation in the ankle and foot global extremities market.

This is a tremendous milestone for orthopaedics and the obvious trend towards patient specific 3D printed implants. In cases of implant revision, limb salvage, and trauma, often there are no clinically available devices to address the patient's condition. This is where 3D printed patient specific implants are making significant clinical impacts, according to Greg Kowalczyk, president of Additive Orthopaedics.

In several patients, its lattice structures have shown close to 90% boney in-growth after six months using no biologics. It is excited to now offer these as patient specific solutions, added Brian McLaughlin, VP of Engineering and Operations,

According to the company, it has seen over 1000 devices implanted since their commercial launch in early 2017 as well as closed a Series B Round of USD1m.