Zimmer Biomet Receives FDA 510(k) Clearance for Unite3D Bridge Fixation System

By Julie A. Vetalice

Zimmer Biomet received FDA 510(k) clearance for the Unite3D™ Bridge Fixation System, 3D-printed technology designed for use in foot and ankle arthrodesis.

Unite3D is made from OsseoTi® porous metal technology which mimics the structure of cancellous bone. It includes an osteoconductive matrix to support biological incorporation, as well as a solid internal framework for added strength and rigidity. The implant is available in nine sizes and employs single-use instrumentation.

Source: Zimmer Biomet, Inc.


The 16 manufacturers profiled in NOTABLE U.S. COMPANIES IN FRACTURE REPAIR also seek to innovate through product design, manufacturing and delivery. Those companies are:

Audax Medical ♦ Conventus Orthopaedics ♦ DGIMED ORTHO ♦ Element Orthopedics ♦ Emerge Medical ♦ Flower Orthopedics ♦ GenOssis ♦ IlluminOss Medical ♦ MBD Medical ♦ OrthoClip ♦ Paragon 28 ♦ Sonoma Orthopedic Products ♦ Stabiliz Orthopaedics ♦ Tissue Regeneration Systems ♦ Tyber Medical ♦ Woven Orthopedic Technologies

This 2014 report is now available as a complimentary download for ORTHOWORLD Members. Others may purchase immediate access for $195.

Product Labels: Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory