Julie A. Vetalice, Author at ORTHOWORLD

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

OrthoSensor in Strategic Partnership with Electronics Company IM-Tech

Company Updates Competitive Landscape

OrthoSensor entered into a partnership with IM-Tech to support R&D collaboration, manufacturing and investments in electronics technology in the global commercialization of the VERASENSE™ sensor.

Mar 08, 2016

NuVasive to Acquire Mega Surgical, Brazilian Distributor

Competitive Landscape Mergers & Acquisitions

NuVasive entered into a definitive agreement to acquire Mega Surgical, its exclusive distributor in Brazil. The transaction is expected to close within 1Q16.

Mar 07, 2016

FDA Accepts Vericel’s BLA for MACI for in Knee Cartilage Defects

Orthobiologics ORTHOFLASH

FDA has accepted for filing Vericel’s BLA for MACI™, matrix-applied characterized autologous cultured chondrocytes intended to treat adult symptomatic knee cartilage defects.

Mar 07, 2016

FDA Clearance of Stryker Tritanium PL Posterior Lumbar Cage

ORTHOFLASH Spine

Stryker Spine announced FDA 510(k) clearance of Tritanium® PL, a highly-porous posterior lumbar cage manufactured via 3D additive manufacturing. Launch will occur in 2Q16.

Mar 04, 2016

Zimmer Biomet Secures Global Distribution Agreement with CelgenTek

Company Updates Competitive Landscape

Zimmer Biomet entered into an exclusive global distribution agreement for CelgenTek Innovations’ N-Force Fixation System® and iN3 Cement.

Mar 04, 2016

ulrich medical USA Launches uNion Cervical Plate

ORTHOFLASH Spine

ulrich medical USA launched uNion®, a titanium alloy cervical plate for stabilization and anterior fixation as an adjunct to fusion.

Mar 03, 2016

Zimmer Biomet Launches Enhancements to Knee Portfolio

Joint Replacement ORTHOFLASH

Zimmer Biomet launched the Persona® Medial Congruent™ Bearing and OsseoTi® Tibial Sleeves.

Mar 03, 2016

DePuy Synthes Partners with Bundled Payment Expert

Company Updates Competitive Landscape

DePuy Synthes entered into an exclusive strategic alliance with Value Stream Partners to facilitate customers’ implementation of bundled payment programs for hip and knee replacement.

Mar 03, 2016

Xtant Medical Receives CE Mark for Aranax and Irix-A

ORTHOFLASH Spine

Xtant Medical received CE Mark approval for the Aranax™ cervical plate and the Irix-A™ standalone anterior lumbar fusion device.

Mar 03, 2016

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