Julie A. Vetalice, Author at ORTHOWORLD

United Orthopedic Corporation Enrolls 1st U.S. Patient in Hip Replacement System Follow-Up Study

United Orthopedic Corporation commenced patient enrollment in a U.S. follow-up study of the U-Motion II+ Acetabular System and UTF Reduced Stem in primary total hip arthroplasty.

Feb 23, 2016

Bioventus Acquires U.S. Distribution Rights to GELSYN-3 HA Injection

Company Updates Competitive Landscape

Bioventus entered into a multi-year agreement with Institut Biochimique, gaining exclusive U.S. distribution rights for GELSYN-3™ 3-injection hyaluronic acid product for pain relief associated with knee OA.

Feb 23, 2016

Materialise, Mathys to Collaborate on Shoulder Guide System

Company Updates Competitive Landscape

Materialise entered into an agreement with Mathys for use of 3D surgical planning software and patient-specific surgical guides with Mathys’ shoulder replacement systems.

Feb 18, 2016

FDA Issues Final Order on PMAs for Metal-on-Metal Hips

Joint Replacement ORTHOFLASH

FDA issued a final order requiring OEMs to submit a premarket approval application for certain metal-on-metal total hip replacement devices.

Feb 18, 2016

FDA Panel Convenes to Discuss Medtronic’s DIAM Spinal Stabilization System

ORTHOFLASH Spine

On 2/19/16, FDA’s Orthopaedic and Rehabilitation Devices Panel will meet regarding the PMA for Medtronic’s DIAM™ Spinal Stabilization System.

Feb 18, 2016

ALLOB Phase IIA Spinal Fusion Trial Update

Orthobiologics ORTHOFLASH

Bone Therapeutics has treated 12 patients in the ALLOB® Phase IIA spinal fusion trial, and reports no safety concerns.

Feb 17, 2016

EOS imaging Obtains Innovative Technology Status in Korea

ORTHOFLASH Robotics/Tech

The EOS imaging platform was granted Innovative Technology status in Korea, recognizing EOS as a unique modality worthy of a new reimbursement code with higher coverage than conventional X-rays.

Feb 16, 2016

Silver Bullet Therapeutics Grows IP Portfolio

ORTHOFLASH Trauma

Silver Bullet Therapeutics was allowed a U.S. patent, "Bone Implants for the Treatment of Infection."

Feb 16, 2016

Study results: Episealer may stop or significantly slow the process leading to OA

Joint Replacement ORTHOFLASH

Study results suggest that a permanent bond may form between cartilage and the hydroxyapatite coating of Episurf’s Episealer® device, suggesting that implantation may stop or significantly slow the progression to OA.

Feb 15, 2016

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

Company Updates Competitive Landscape

Strategic orthopaedic-related 510(k)s issued in January 2016 include: Half Dome PLIF System (Astura Medical*), Cannulated Screw System (Epic Extremity*), Rosa Spine (Medtech*), IFS Fixation Scaffold (Metric Medical), dynaMX MX Tabbed Staple (MX Orthopedics), Hard Carbon Coated Drill Bit (Renovo Life*), Polyscrew Pedicle Fixation System (Senecka Spine*), Interbody System (Spine Innovation*), VerteLP IBF Device (VGI Medical*)

Feb 12, 2016

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