Strategic Orthopaedic-related 510(k)s issued in December 2015

By Julie A. Vetalice

Each month, ORTHOWORLD examines updates to FDA's orthopaedic-related 510(k) database and highlights those products deemed strategic, defined as a company's first 510(k) clearance, first clearance in a segment that is new to the company, clearance for a type of device not formerly marketed by a company, etc.

In the following list, companies receiving a first orthopaedic-related 510(k) are denoted with an asterisk.

Strategic orthopaedic-related 510(k)s issued in December 2015 include: Fusion Implant System (Bio2 Technologies), Spinal Fixation System (Changzhou Dingjian Medical), Metallic Intramedullary Nail (Changzhou Waston Medical), Latitude-C Cervical Interbody Spacer (DeGen Medical), V-Steady and V-Fast Bone Cements (G21*), Firefly Pedicle Screw Navigational Guide (Mighty Oak Medical*), Apex Revision Knee (OMNIlife sciences), Remedy Shoulder Spacer (Osteoremedies*), Internal Joint Stabilizer - Elbow (Skeletal Dynamics)

Product Labels: Knee Replacement, Spinal Fusion, Upper Extremity

Tags: 510(k) Clearance, Regulatory