Strategic Orthopaedic-related 510(k)s issued in January 2016

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 January 2016 include: Half Dome PLIF System (Astura Medical*), Cannulated Screw System (Epic Extremity*), Rosa Spine (Medtech*), IFS Fixation Scaffold (Metric Medical), dynaMX MX Tabbed Staple (MX Orthopedics), Hard Carbon Coated Drill Bit (Renovo Life*), Polyscrew Pedicle Fixation System (Senecka Spine*), Interbody System (Spine Innovation*), VerteLP IBF Device (VGI Medical*)