FDA Issues Final Order on PMAs for Metal-on-Metal Hips
FDA issued a final order requiring OEMs to submit a premarket approval application for certain metal-on-metal total hip replacement devices.
FDA Panel Convenes to Discuss Medtronic’s DIAM Spinal Stabilization System
On 2/19/16, FDA's Orthopaedic and Rehabilitation Devices Panel will meet regarding the PMA for Medtronic's DIAM™ Spinal Stabilization System.
ALLOB Phase IIA Spinal Fusion Trial Update
Bone Therapeutics has treated 12 patients in the ALLOB® Phase IIA spinal fusion trial, and reports no safety concerns.
EOS imaging Obtains Innovative Technology Status in Korea
The EOS imaging platform was granted Innovative Technology status in Korea, recognizing EOS as a unique modality worthy of a new reimbursement code with higher coverage than conventional X-rays.
Silver Bullet Therapeutics Grows IP Portfolio
Silver Bullet Therapeutics was allowed a U.S. patent, "Bone Implants for the Treatment of Infection."
Study results: Episealer may stop or significantly slow the process ...
Study results suggest that a permanent bond may form between cartilage and the hydroxyapatite coating of Episurf's Episealer® device, suggesting that implantation may stop or significantly slow the progression to OA.
Strategic Orthopaedic-related 510(k)s issued in January 2016
Strategic orthopaedic-related 510(k)s issued in January 2016 include: Half Dome PLIF System (Astura Medical*), Cannulated Screw System (Epic Extremity*), Rosa Spine (Medtech*), IFS Fixation Scaffold (Metric Medical), dynaMX MX Tabbed Staple (MX Orthopedics), Hard Carbon Coated Drill Bit (Renovo Life*), Polyscrew Pedicle Fixation System (Senecka Spine*), Interbody System (Spine Innovation*), VerteLP IBF Device (VGI Medical*)
Medline Expands its Foot/Ankle trauma Portfolio
Medline launched the UNITE® Foot Plating system, ARROW-LOK® Digital Fusion system and DBM putty/demineralized cancellous sponge products.
Zimmer Biomet Receives FDA 510(k) Clearance for Unite3D Bridge Fixation ...
Zimmer Biomet received FDA 510(k) clearance for the Unite3D™ Bridge Fixation System, 3D-printed technology designed for use in foot and ankle arthrodesis.
RTI Surgical to License OPM’s OsteoFab 3D Printing Technology
RTI Surgical entered into an agreement with Oxford Performance Materials, gaining exclusive license for use of OsteoFab® additive manufacturing technology for spinal applications across the U.S.