In2Bones FDA 510(k) Clearance for Extremity Fixation Implants

By Julie A. Vetalice

In2Bones USA received FDA 510(k) clearance for its 5MS™ Fracture Repair and CoLag™ Locking Compression Screw systems.

5MS features interchangeable plates/screws delivered sterile in individually packaged tubes; single-use instruments are sterile-packaged in a disposable tray. A reusable color-coded instrument set is also available.

The CoLag screw, also delivered in sterile packaging, offers differential, dual-pitch threads with a low-profile head designed to create a compression lock between fragment and fracture.

Since launch of its U.S. subsidiary in 3Q16, In2Bones has introduced extremity repair products in the U.S. such as the NeoView® PEEK Distal Radius Plate, NeoSpan® SuperElastic Compression Staple, Reference Toe System™, AlloAid® PIP, AlloAid® Nail and the CoLink™ Forefoot Plating System.

Sources: In2Bones Global, Inc.; ORTHOWORLD inc.

Images courtesy of In2Bones

Product Labels: Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory