Julie A. Vetalice, Author at ORTHOWORLD

In2Bones Launches TriWay TibioTaloCalcaneal Nail Arthrodesis System

In2Bones commenced global launch of the TriWay® TibioTaloCalcaneal Nail Arthrodesis System to treat arthritis, failed total ankle replacement, talar deficiencies, etc.

Apr 30, 2019

Artoss Gains FDA Clearance of NanoBone SBX Putty for Standalone Use in Fusion

Orthobiologics ORTHOFLASH

Artoss gained FDA 510(k) clearance to market NanoBone® SBX Putty for standalone use in posterolateral spinal fusion.

Apr 25, 2019

ApiFix Completes Series B Financing

Investments The Numbers

ApiFix completed its Series B financing round and is preparing for U.S. commercial launch of its MID-C System to treat pediatric scoliosis.

Apr 24, 2019

Konica Minolta Healthcare Gains FDA Clearance for Dynamic Digital Radiography

Joint Replacement ORTHOFLASH

Konica Minolta Healthcare Americas received FDA 510(k) clearance to market Dynamic Digital Radiography enhanced x-ray imaging that can capture movement in a single exam.

Apr 24, 2019

NuVasive Cohere Porous PEEK Comparative Study Results

ORTHOFLASH Spine

NuVasive's Cohere® Porous PEEK interbody demonstrated clear benefits in promoting improved early outcomes in ACDF procedures when compared to both structural allograft and smooth PEEK.

Apr 23, 2019

Safe Orthopaedics’ SteriSpine PS Gains Japan Regulatory Approval

ORTHOFLASH Spine

Safe Orthopaedics received regulatory registration in Japan for the SteriSpine PS system to treat spinal fractures.

Apr 23, 2019

Orthofix M6-C Disc in First U.S. Patients Following PMA

ORTHOFLASH Spine

Orthofix Medical announced first commercial U.S. implants of the M6-C cervical disc following FDA Premarket Approval of the device.

Apr 23, 2019

Regulatory Report: 42 Companies that Received their First Orthopedic-Related FDA 510(k) in 2018

Company Updates Competitive Landscape

Small companies around the world continue to seek access to the expansive U.S. market. In 2018, 42 companies received their first ever orthopedic-related FDA 510(k) or first FDA 510(k) in a new market segment. The companies and products we mention here are excerpted from chapters of the upcoming 2019 installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT.

Apr 23, 2019

Shoulder Innovations Announces Long Term Data for Inset Glenoid

Joint Replacement ORTHOFLASH

Shoulder Innovations' InSet Glenoid demonstrated long-term efficacy and safety in total shoulder replacement to reconstruct deficient, arthritic glenoid bone.

Apr 18, 2019

Medicrea Gains Additional FDA Clearance for Surgical Planning Software

ORTHOFLASH Spine

Medicrea enhanced the UNiD ASI (Adaptive Spine Intelligence) platform with addition of a device selection and surgical planning service, integrating a complete database of all Medicrea spine implants.

Apr 18, 2019

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