September 22, 2017 | Blake Mossy
Mazor Robotics received CE Mark approval for its Mazor X Surgical Assurance Platform. The approval allows its commercial partner, Medtronic, to market the Mazor X in the European Union, as well as other countries that recognize the CE Mark.
Stryker Spine received 510(k) clearance from the FDA for its 3D-printed Tritanium C Anterior Anterior Cervical Cage, a porous titanium material designed for bone in-growth and biological fixation. The device utilizes a large open central graft window and lateral windows to help reduce stiffness and minimize subsidence, as well as serrations to ensure fixation and maximize surface area.
PRODUCT INTRODUCTION & UPDATE
Bone Solutions launched its OsteoCrete system, a bone void filler which incorporates magnesium to assist with bone repair and generation. The system is resorbable, injectable, moldable and biocompatible, and is designed for the treatment of complex sports-related injuries and musculoskeletal extremities trauma.
Paragon 28 launched its Baby Gorilla Mini Plating system designed specifically for the 5th metatarsal. The system includes multiple styles of hook plates and non-hooked compression plates comprise this launch, along with procedure-specific instrumentation. The modular system can use the same screws and instrumentation used by all other Baby Gorilla plates.
Artoss entered into a Defense Acquisition Purchasing Agreement (DAPA) with Owens & Minor for U.S. Department of Defense (DoD) purchase of all NanoBone graft products. Artoss is the exclusive North American distributor for NanoBone in orthopedic procedures. NanoBone’s synthetic bone grafting material incorporates nano-crystalline particles of hydroxyatite (HA) similar to HA particles naturally occurring in human bone.
Band-LOK received two patents from the United States Patent and Trademark Office (USPTO) for its proprietary Tether Clamp and Implantation System. The new patents cover the clamp housing assembly technology and the method for providing stabilization as a bone anchor during an orthopedic surgical procedure.
Zyga Technology received expanded coverage from Highmark, for its minimally invasive SImmerty Sacroiliac joint fusion system. Highmark, which formerly covered only one implant technology, has expanded its policy to now include all FDA-cleared instrumentation for this indication including cages or screws, with or without bone graft.
Bone Therapeutics entered into an exclusive, royalty-bearing license agreement with Asahi Kasei to develop and commercialize PREOB autologous bone cell therapy in Japan, with an option to include China, Korea and Taiwan. Under the terms of the agreement, Bone Therapeutics will provide manufacturing expertise, while Asahi Kasei will gain exclusive rights to develop and market PREOB for the treatment of osteonecrosis of the hip and other orthopedic applications.
Integra LifeSciences announced the first patient enrollment in its Candence Total Ankle System non-randomized, prospective, multi-center post-market study. The primary objective of the study is to evaluate 2-year implant survivorship in subjects who received the Cadence Total Ankle System for primary ankle arthroplasty. Implant survivorship will further be evaluated at 5 and 10 years post-operatively.