US, EU Regulatory Approvals for New Orthofix Bone Growth Stimulators
Orthofix announced U.S. FDA premarket and European CE Mark approval for next-gen CervicalStim™ and SpinalStim™ bone growth stimulators. Jan 09, 2017
Medicrea Submits 510(k) for 3D-Printed Titanium Spinal Interbody Devices
Medicrea filed its FDA 510(k) submission for 3D-printed titanium interbody devices with compatible UNiD™ Lab surgical planning and analytical services. Jan 09, 2017
CartiHeal Performs First Clinical Cases with New Unicondylar Implant
CartiHeal announced initial cases in Europe with the next-gen version of the Agili-C™ unicondylar implant, designed to treat large cartilage lesions. Jan 09, 2017
JNJ Launches New Care-Centric Services
Johnson & Johnson Medical Devices, parent company to DePuy Synthes, announced CareAdvantage and Orthopaedic Episode of Care Approach services for healthcare systems. Jan 09, 2017
SI-BONE Announces iFuse Implant System Warranty
SI-BONE enacted a warranty program for the iFuse Implant System®, indicated for fusion for certain disorders of the sacroiliac joint. Jan 09, 2017
Amedica’s First Taurus Pedicle Screw System Surgery
Amedica announced successful completion of the first surgery using the Taurus™ Pedicle Screw. Jan 09, 2017
Corin Hips Awarded 5A* ODEP Rating
Corin was awarded a 5A* ODEP rating from the Orthopaedic Data Evaluation Panel for its MiniHip™ bone conserving hip, MetaFix™ collarless cementless total hip and the Trinity™ advanced bearing acetabular system. Jan 06, 2017
Globus Medical Receives CE Mark for Excelsius GPS
Globus Medical received CE Mark approval for the Excelsius GPS™ robotic trajectory guidance and navigation system. Jan 06, 2017
EU Patent for JAZZ Implant Universal Tensioning System
Implanet was granted a European patent for the JAZZ® implant universal tensioning system. Jan 05, 2017
Draft Guidance Announced: 510(k) Submissions for Bone Anchors
FDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors. Jan 04, 2017
