November 3, 2017 | Blake Mossy
Intellijoint Surgical received 510(k) clearance from the FDA for its intellijoint HIP 3D Mini-Optical Navigation System for use in revision total hip replacement. The system aims to provide surgeons with measurements for cup position, leg length and offset for THA and requires no pre-operative or intra-operative imaging. intellijoint HIP is available for use in Anterior, Posterior and lateral approaches and allows existing components to be evaluated without removal, which aims to reduce surgical risk and complications.
IntraFuse received 510(k) clearance from the FDA for its FlexThread Fibula Pin system, indicated for percutaneous fixation of distal fibula fractures. The distal end of the fibula pin implant is a flexible, intramedullary screw, the proximal end is a rigid, high-strength intramedullary rod. Upon insertion, the rigid rod spans and supports the fracture while the flexible screw portion bends as needed to thread into the intramedullary canal, supporting proper bone alignment.
Medacta received 510(k) clearance from the FDA for its 3DMetal Tibial Cones indicated for knee revision surgery. The system is comprised of 3DMetal, a 3D printed advanced biomaterial, that aims to enable direct structural and functional connection with the bone through an interconnecting pore structure similar to the cancellous bone structure.
Pinnacle Spine filed an application with the FDA seeking 510(k) clearance for its lateral InFill Lumbar Fusion Systems with PEEK-OPTIMA HA Enhanced polymer from Invibio Biomaterial Solutions. They system is comprised of a hydroxyapatite enhancement which aims to support osteoconductivity that encourages bone ongrowth on all surfaces, while providing reduced stressed shielding and artifact-free imaging.
PRODUCT INTRODUCTION & UPDATE
Claris Healthcare launched its Claris Reflex, a coaching system designed to monitor recovery of total knee replacement patients over 65 years of age. Reflex serves orthopedic centers covered by the Comprehensive Care for Joint Replacement, Bundled Payment for Care Improvement and private insurance bundled payment initiatives, as a measure to help maximize profits and reduce readmissions.
Consensus Orthopedics launched its TracPatch in Australia, a wearable device designed to allow healthcare providers the ability to plan and monitor their patient’s orthopedic recovery. Placed on the lower leg just below the knee, the device sends activity data such as range of motion (ROM), ambulation, exercise compliance and wound site temperature measurements to healthcare providers.
Johnson & Johnson Health and Wellness Solutions (JNJ) launched its Health Partner, a platform of digital tools to prepare patients for hip and knee surgery. The platform is comprised of a website that provides education and resources before treatment begins, a mobile application to help guide patient through surgical preparation and recovery and a care portal designed for providers and health systems to enable real-time interaction.
Maxx Orthopedics launched its Freedom PCK Revision System globally and announced its first procedures performed in India and several Gulf countries. The system combines Freedom Stemmed Tibial components with PCK femoral components and constrained liners and aims to offer a bone conserving, low profile revision system.
SeaSpine launched its OsteoStrand Demineralized Bone Fibers, designed to maximize the osteoinductive content while aiming to provide improved conductive matrix during fusion for the treatment of spinal disorders. The company also announced the initial surgeries using its OsteoStrand system.
Corin and Ossis entered in a collaboration agreement with 3D printing technology, intended for use in patient-specific solutions for complex revision surgery and tumor resection. Corin’s 3D printing technology was used to manufacture its Trinity Plus, a revision hip acetabular solution. Under the terms of the agreement, Corin’s technologies will complement Ossis’ patient-specific, custom-made implants.
Exactech announced the completion of its first revision knee produce using its Truliant instrumentation, supporting mechanical and ExactechGPS computer-assisted surgical approaches, and is now available for primary and revision surgery. The system is designed to provide visual and audible feedback during the procedure, offering flexion/extension gap management and supporting proper alignment.
Arthrosurface entered into an agreement to acquire acellular dermal stabilization device technology, including the intellectual property rights to and associated with this technology from WASAS, based in Fort Lauderdale, Florida. The company plans to use this technology to develop and market a platform of novel methods to be used to correct orthopedic challenges in multiple therapeutic areas.
Xtant Medical entered into a distribution agreement with curasan for the distribution of its Matriform synthetic scaffolds in North America. The system is comprised of pure phase Beta-Tricalcium Phosphate and porcine collagen, and interconnected porosity with a variety of micro, meso, and macro pores.