FDA Clearance for Additive Orthopaedics’ Locking Lattice Plate

By Julie A. Vetalice

Additive Orthopaedics received FDA 510(k) clearance for a 3D-printed Locking Lattice Plating System, designed to address stabilization and fusion of fractures, osteotomies and arthrodesis of small bones.

The plates can be implanted alone with locking or non-locking screws, or with the company's 3D-printed bone segments through use of a connection screw.

This is the company's third 510(k) clearance leveraging additive manufacturing, and its fifth product line, comprising 3D-printed core products, biologics and custom devices for limb salvage and complex revisions. Surgeons have implanted >300 Additive Orthopaedics devices since first full commercial product launch at the end of 2016.

Source: Additive Orthopaedics, LLC; ORTHOWORLD Inc.

Tags: 510(k) Clearance, Regulatory