Julie A. Vetalice, Author at ORTHOWORLD

Tyber Medical Expands FDA 510(k) Clearance of Headed and Snap-Off Screws

Tyber Medical received FDA 510(k) clearance of its headed and snap-off screws with configurations incorporating the proprietary BioTy™ modified surface treatment.

Jun 15, 2016

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

Company Updates Competitive Landscape

Strategic orthopaedic-related 510(k)s issued in May 2016 include: Navio Indication for TKA (Blue Belt Technologies), Enza Zero-profile Anterior Interbody Fusion System (Camber Spine), CSR Shoulder System (Catalyst OrthoScience*), Stropp/Single Tunnel Repair of Plantar Plate (CrossRoads Extremity), Cervical Interbody Fusion System (Evolution Spine*), Flip Button Suture Anchor (First Ray), Neofuse HA Enhanced PLIF/TLIF (HT Medical*), HC Spinal System (Hung Chun Bio-S*)

Jun 14, 2016

Bone Biologics Signs Option to License Nell-1 Bone Growth Factor for Use in Osteoporosis

Company Updates Competitive Landscape

Bone Biologics signed an option agreement with UCLA for an opportunity to exclusively license the use of Nell-1 bone growth factor in the treatment of osteoporosis.

Jun 14, 2016

KB Medical Receives CE Mark Approval for AQrate Spinal Robotic Assistance System

ORTHOFLASH Robotics/Tech

KB Medical received approval under the CE Mark for its AQrate™ Robotic Assistance system, indicated for use in general spinal surgery.

Jun 14, 2016

ISTO Technologies Acquired by Private Equity Firm

Competitive Landscape Mergers & Acquisitions

The commercial operations of ISTO Technologies, an orthobiologics company, were acquired by private equity firm Thompson Street Capital Partners. Transaction terms were not disclosed.

Jun 13, 2016

AlloSource Launches AlloFuse Cortical Fibers and Fiber Boats

Orthobiologics ORTHOFLASH

AlloSource launched AlloFuse® Cortical Fibers and AlloFuse Fiber Boat demineralized cortical fiber allografts for a variety of spine and orthopaedic procedures.

Jun 13, 2016

Spineart Announces BAGUERA C Milestone

ORTHOFLASH Spine

As of 2Q15, >15,000 of Spineart’s BAGUERA® C cervical disc replacement devices have been successfully implanted worldwide.

Jun 13, 2016

Amedica Submits Response to FDA for Clearance of Composite Interbody Spinal Device

ORTHOFLASH Spine

Amedica submitted its responses to FDA in relation to the CASCADE clinical trial, and expects a final determination from FDA within 60 days.

Jun 13, 2016

curasan to Expand in the U.S. and China

Company Updates Competitive Landscape

curasan will invest in targeted expansion of sales and marketing activities in the U.S. and China. The company markets CERASORB® bone void filler products.

Jun 13, 2016

Titan Spine Enhances Endoskeleton Warranty

ORTHOFLASH Spine

Titan Spine is amending its device warranty to provide a free replacement if any Endoskeleton® interbody fusion devices delaminate or generate particulate debris during implantation.

Jun 13, 2016

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