Strategic orthopaedic-related 510(k)s issued in March 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.

Joinix Cannular System (Aju Pharm*), Unicompartmental Knee (Bodycad*), Microfet 2 Dynamometer (Hoggan Scientific), Flex-Thread Clavicle Pin (Intrafuse*), Evolution Revision Tibial System (MicroPort Orthopedics)

Product Labels: Knee Replacement, Upper Extremity

Tags: 510(k) Clearance, Regulatory