Julie A. Vetalice, Author at ORTHOWORLD

Study results: Episealer may stop or significantly slow the process leading to OA

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.

Feb 15, 2016

Strategic Orthopaedic-related 510(k)s issued in January 2016

Company Updates Competitive Landscape

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*)

Feb 12, 2016

Medline Expands its Foot/Ankle trauma Portfolio

ORTHOFLASH Trauma

Medline launched the UNITE® Foot Plating system, ARROW-LOK® Digital Fusion system and DBM putty/demineralized cancellous sponge products.

Feb 12, 2016

Zimmer Biomet Receives FDA 510(k) Clearance for Unite3D Bridge Fixation System

ORTHOFLASH Trauma

Zimmer Biomet received FDA 510(k) clearance for the Unite3D™ Bridge Fixation System, 3D-printed technology designed for use in foot and ankle arthrodesis.

Feb 12, 2016

RTI Surgical to License OPM’s OsteoFab 3D Printing Technology

Company Updates Competitive Landscape

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.

Feb 12, 2016

National Government Services Issues Coverage for MIS SI Joint Fusion

ORTHOFLASH Spine

National Government Services issued a positive local coverage determination for MIS SI joint fusion, including SI-BONE’s iFuse procedure, effective 4/1/16.

Feb 12, 2016

Wenzel Spine Receives FDA 510(k) Clearance for VariLift-LX

ORTHOFLASH Spine

Wenzel Spine received FDA 510(k) clearance to market VariLift®-LX as a lumbar interbody fusion device for standalone use.

Feb 11, 2016

Regentis Biomaterials Raises $15MM for U.S. Pivotal Clinical Trial

Investments The Numbers

Regentis Biomaterials closed a US $15MM Series D investment round. Funds will primarily support a pivotal U.S. clinical trial of GelrinC®, a cell-free implant for the treatment of articular knee cartilage injuries.

Feb 10, 2016

MX Orthopedics Receives FDA Clearance for dynaMX Compression Staple

ORTHOFLASH Trauma

MX Orthopedics received FDA 510(k) clearance to market the dynaMX™ Compression Staple, a superelastic Nitinol-based device.

Feb 10, 2016

Five-Year Results of Mobi-C Cost Utility Analysis

ORTHOFLASH Spine

Studies concluded that, for patients with 2-level degenerative disc disease, cervical total disc replacement appears to be highly cost-effective vs. ACDF, and supports greater quality of life at less cost.

Feb 10, 2016

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