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Medical Devices / Submissions and Approvals

Additive Orthopedics Announces FDA Clearance of 3D Printed Bone Segments

May 21, 2018

Additive Orthopedics received 510(k) clearance for its patient-specific 3D printed bone segments, used to address internal bone fixation in the ankle and foot.

The printed bone segments are used in certain cases of limb salvage, trauma and implant revision when there are few clinically available devices to address the patient’s condition.

The segments use a lattice structure to promote bone-in growth instead of older, more open types of structures that use biologics for osteosynthesis.

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