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

Envision 3D: Image Guidance System (7D Surgical*); Sphynx Anterolateral Plate (Eden Spine); Destiknee Total Knee (Meril Healthcare*); Hubble II Lumbar Interbody Fusion System (Orbbo Surgical*)

Product Labels: Knee Replacement, Surgical Navigation, Spinal Fusion

Tags: 510(k) Clearance, Regulatory