Julie A. Vetalice, Author at ORTHOWORLD

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

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

Tyber Medical Launches TyWedge Evans And Cotton Osteotomy Wedge Systems

ORTHOFLASH Trauma

Tyber Medical commenced full market launch of its TyWedge™ Osteotomy Wedge System, featuring TyPEEK® proprietary titanium plasma-sprayed PEEK coating specifically indicated for fusion.

Feb 09, 2016

Ellipse Technologies Withdraws IPO

Investments The Numbers

Ellipse Technologies withdrew its plans for a US $75MM initial public offering, filed in 4Q15, in light of its pending acquisition by NuVasive.

Feb 09, 2016

Tentative Date for FDA Advisory Panel Review of Cartiva SCI

ORTHOFLASH Sports Medicine

FDA tentatively scheduled a 2Q16 meeting of the Orthopaedic and Rehabilitation Devices Panel to review Cartiva’s Premarket Approval Application for the Synthetic Cartilage Implant in the treatment of great toe osteoarthritis.

Feb 09, 2016

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