FDA Proposes Reclassification of Posterior Cervical Screws
FDA is proposing to classify posterior cervical screw systems into Class II (special controls) and to continue to require premarket notification for the devices.
Medtech Logs First Sale of ROSA Spine in the U.S.
Medtech announced the 1st sale of its ROSA™ Spine robotic surgery system in the U.S.
Strategic Orthopaedic-related 510(k)s issued in February 2016
Strategic orthopaedic-related 510(k)s issued in February 2016 include: C-VBR (Cardinal Spine), Lateral Interbody System (Cogent Spine), M-Fix Acromioclavicular Device (Coracoid Solutions*), Extremity Plate System (Epic Extremity), Winch Kyphoplasty Gauge (G21), MiniARS Screws (Overmed*), Irene Locking Compression Plate (Tianjin Zhengtian Medical Instrument*), trauma Screw (Tyber Medical), Comprehensive SRS/Nexel Elbow (Zimmer Biomet)
Wenzel Spine Announces Limited Release of the Next-Gen VariLift-LX
Wenzel Spine commenced limited launch of the VariLift®-LX system for minimally invasive lumbar fusion. Full launch is planned for spring 2016.
NuVasive Receives Regulatory Approval of ReLine™ Posterior Fixation in Japan
NuVasive received regulatory approval for ReLine™ posterior fixation technology in Japan. Launch will commence later in 2016 and continue into 2017.
BioMedical Enterprises Launches the Elite Nitinol Bone Fixation System
BioMedical Enterprises (BME) commenced U.S. launch of the BME Elite® Nitinol Bone Fixation system, designed to offer high strength, stiffness and rotational stability for high-load applications.
Life Spine Receives FDA Clearance for PROLIFT Expandable Interbody System
Life Spine received FDA 510(k) clearance to market the PROLIFT® Expandable Interbody System for use in minimally invasive PLIF, TLIF and oblique approaches.
Instratek Launches HammerFIT Extremity Reamers
Instratek commenced U.S. launch of the HammerFIT™ Extremity Reamer for hammertoe surgery.
Medtronic Launches AVILA Interbody Fusion Devices in the EU
Medtronic commenced EU launch of AVILA™ devices, intended for use in open and minimally invasive anterior and oblique lumbar interbody fusion from L2-S1 levels.
FDA Panel to Convene on PMA for Cartiva’s Synthetic Cartilage ...
On 4/20/16, FDA's Orthopaedic and Rehabilitation Devices Panel will meet regarding the PMA for Cartiva's Synthetic Cartilage Implant, an organic polymer-based biomaterial designed to mimic biologic cartilage.