Implanet Initiates Prospective, Multicenter Clinical Study of JAZZ Band
Implanet commenced a prospective, multicenter clinical study to document outcomes with the JAZZ Band™ implant in adult degenerative and deformity indications. Mar 14, 2016
Medicrea Launches UNiD Lab Support for Patient-Specific Spine Surgery
Medicrea has launched UNiD™ Lab Services, including real-time support for pre-op planning of spinal procedures, order fulfillment for the UNiD patient-specific rod and detailed post-op analysis. Mar 14, 2016
Maxx Orthopedics Launches Freedom PCK Revision Knee
Maxx Orthopedics announced launch and initial procedures using the Freedom® PCK revision knee. Mar 11, 2016
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. Mar 11, 2016
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. Mar 10, 2016
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) Mar 10, 2016
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. Mar 09, 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. Mar 09, 2016
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. Mar 09, 2016
FDA Panel to Convene on PMA for Cartiva’s Synthetic Cartilage Implant
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. Mar 08, 2016
