Julie A. Vetalice, Author at ORTHOWORLD

Corin Receives FDA Clearance to Market the Optimized Positioning System

Corin received FDA 510(k) clearance to market the Optimized Positioning System (OPS™), reportedly the first FDA-cleared technology to support functional, patient-specific component alignment in total hip replacement.

Jun 09, 2016

Avitus Orthopaedics Receives 510(k) Clearance, Launches Avitus Bone Harvester

Orthobiologics ORTHOFLASH

Avitus Orthopaedics launched pilot sales of the Avitus™ Bone Harvester.

Jun 08, 2016

Xtant Medical, Pinnacle Spine Distribution Agreement

Company Updates Competitive Landscape

Xtant Medical and Pinnacle Spine entered into a joint agreement to expand distribution of Pinnacle’s InFill® Lateral Lumbar Interbody Fusion system.

Jun 08, 2016

MX Orthopedics Receives FDA Clearance for the dynaMX Nitinol Compression Screw

ORTHOFLASH Trauma

MX Orthopedics received FDA 510(k) clearance to market the dynaMX™ Nitinol Compression Screw.

Jun 07, 2016

Medtronic Acquires Responsive Orthopedics

Competitive Landscape Mergers & Acquisitions

Medtronic acquired Responsive Orthopedics, a start-up focused on sales of low-cost hip and knee replacements. A primary knee is slated for commercial U.S. availability within 1H17, followed by a primary hip in 1H18.

Jun 07, 2016

Zimmer Biomet Acquiring LDR

Competitive Landscape Mergers & Acquisitions

Zimmer Biomet entered into a definitive agreement to acquire LDR for US $37/share in cash, for a transaction valued at ~$1.0BB with an expected 3Q16 close.

Jun 07, 2016

Flower Orthopedics Launches Flower E-Kit And IndicationCube

ORTHOFLASH Trauma

Flower Orthopedics commenced full market launch of Flower E-Kit™, containing all required cannulated and plating instruments for midfoot, forefoot and ankle in one single-use package.

Jun 07, 2016

NuVasive Acquiring Biotronic NeuroNetwork for $98 Million

Competitive Landscape Mergers & Acquisitions

NuVasive (NUVA) entered into a definitive agreement to acquire Biotronic NeuroNetwork, a U.S. provider of intraoperative neurophysiological monitoring services, for US $98MM in cash.

Jun 06, 2016

Warning Letter Issued to Zimmer CAS

Company Updates Competitive Landscape

On 5/31/16, Zimmer Biomet received an FDA Warning Letter regarding observed non-conformities at the company’s Zimmer CAS/ORTHOsoft facility in Montreal, Quebec, Canada.

Jun 06, 2016

First Implantations of Vertera Spine Porous PEEK COHERE Cervical Fusion Device

ORTHOFLASH Spine

Vertera Spine announced first implantations with the COHERE™ Cervical Interbody Fusion system. Full market launch is expected in coming months.

Jun 06, 2016

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