Strategic orthopaedic-related 510(k)s issued in November 2016

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. Additional information on select devices is available via links. (For listings with two companies named, the first is the company of record in FDA's database.)

Preference Elite Pedicle Screw System (Amedica); Titanium Porous Fixation Device (Amorchem*); Moss 100 Pedicle Screw System (Biedermann Motech); Persona Partial Knee (Biomet/Zimmer Biomet); AltiVate Anatomic Shoulder, Exprt Revision Hip (Encore Medical/DJO); Initia Total Hip & Bioceram AZUL Head (Kyocera Medical); Virtu C Spinal Implant (Met 1); Interference Screw (Nanova Biomaterials); Fortezza Spinal Stabilization System (Osso Surgical*)

View the full list of orthopaedic 510(k)s for November 2016 here.

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory