Strategic Orthopaedic-related 510(k)s issued in April 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.

Olympic Posterior Spinal Fixation System (Astura Medical); Revival Modular Revision Hip Stem (Corin); Internal Bone Staple, Bicortical Fixation Screw & Washer Nut System (First Ray*); G3 Active Plate Small Fragment System (Genesis Fracture Care); Maxigen Bone Void Filler (Hans Biomed); Osteopal Plus Bone Cement (Heraeus); Pedicle Screw System (icotec); Revolution Spinal Fixation System (Intelligent Implant); Glenoid Positioning System (Materialise); Ultra Telescope (Olympus Winter); White Pearl Preferred Angle Anterior Cervical Plate (Osseus Fusion); Starfuse Interphalangeal Pin, Osteobullet Compression Screw (Phalanx Innovations*)

Tags: 510(k) Clearance, Regulatory