Strategic orthopaedic-related 510(k)s issued in January 2017

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.

Fibulink Syndesmosis Repair Kit (Akros Medical*), Anatomic Total Knee (Amplitude*), Facilis Pedicle Screw System (Baui Biotech*), GEO Bone Screw (Gramercy Extremity Orthopedics*), Roccia ACIF Intervertebral Fusion System (Silony Medical*), Fitbone TAA Intramedullary Lengthening System (Wittenstein Intens*)

View the full list of orthopaedic 510(k)s for January 2017 here.

Product Labels: Spinal Fusion, Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory