Maxx Orthopedics’ First Successful Procedure with Libertas Hip Replacement
Maxx Orthopedics entered the total hip replacement market with introduction of the Libertas® Hip System. May 01, 2019
Centric Medical Launches MTP Plating System
Centric Medical commenced commercial launch of the MTP Plating System, comprising plates, screws and other fixation components to stabilize bone segments in foot/ankle. May 01, 2019
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
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
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
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
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
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
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
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
