PR Newswire05.17.18
Additive Orthopaedics, LLC., a developer of 3D printed orthopedic foot and ankle devices, announced that is has received FDA 510(k) clearance for its Patient Specific 3D Printed Bone Segments, to address internal bone fixation in the ankle and foot.
According to Greg Kowalczyk, president of Additive Orthopaedics, "This is a tremendous milestone for orthopedics 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 Brian McLaughlin, VP of Engineering and Operations, "Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on biologics for osteosynthesis. In several patients, our lattice structures have shown close to 90 percent boney in-growth after 6 months using no biologics. We are excited to now offer these as patient specific solutions."
The company has seen over 1000 devices implanted since their commercial launch in early 2017. The company has recently closed a Series B Round of $1M.
According to Greg Kowalczyk, president of Additive Orthopaedics, "This is a tremendous milestone for orthopedics 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 Brian McLaughlin, VP of Engineering and Operations, "Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on biologics for osteosynthesis. In several patients, our lattice structures have shown close to 90 percent boney in-growth after 6 months using no biologics. We are excited to now offer these as patient specific solutions."
The company has seen over 1000 devices implanted since their commercial launch in early 2017. The company has recently closed a Series B Round of $1M.