March 16, 2018 | Blake Mossy
CTL Medica received 510(k) clearance from the FDA for its MATISSE Ti-PEEK ACIF cage with TiCro technology. The system aims to offer surgeons greater endplate contact surface area and geometric surface morphology for increased mechanical locking at the cage and bone interface. The implant utilized a tapered leading edge for easy insertion and a large graft area, promoting bony fusion.
Exactech received 510(k) clearance from the FDA for its Equinoxe Stemless Shoulder, a bone conserving and canal sparing prosthesis for total shoulder arthroplasty. The system utilizes a single tray of instruments, including a 3D porous structure with optimized pore size, count and porosity. The system incorporates a bone cage for bone through-growth to enhance the probability of biologic fixation.
Orthopedic Designs North America received 510(k) clearance from the FDA for its Talon DistalFix Humeral Nail, a cannulated design available in multiple diameters and lengths. The device is indicated for humeral shaft fractures and aims to eliminate the need for freehand drilling and distal locking screws using Talon DistalFix technology.
PRODUCT INTRODUCTION & UPDATE
K2M launched its YUKON OCT posterior fixation system, designed to support restoration of cervical sagittal balance in the occipito-cervico-thoracic regions. The system utilizes a top-loading polyaxial screw with high angulation and the ability to accommodate rods in two diameters.
Materialise launched its Trumatch Personalized Solutions Shoulders System in collaboration with DePuy Synthes. The system is designed for use in planning shoulder arthroplasty surgery, specifically reverse shoulder and anatomic shoulder arthroplasty procedures. The platforms aims to offer surgeons an online planning platform as well as the ability to order patient-specific 3D printed surgical guides.
Episurf Medical received a patent from the Europeans Patent Office (EPO) for its method and mode for manufacturing a surgical kit for cartilage repair. The patent covers the medical image segmentation process used for joint damage visualization as well as for manufacturing of Episurf Medical’s patient-specific joint implants and surgical instruments.
Kuros Biosciences received a European patent covering its technology for osteoinductive calcium phosphates and their methods of production. The production method creates a surface topography that instructs stem cells and osteoprogenitor cells to differentiate into bone-forming cells. The biphasic calcium phosphate materials on which the MagnetOs system is based, has shown equivalence to autograft in clinically-relevant preclinical models.
Cerapedics received approval from the FDA for an Investigational Device Exemption clinical trial of its P-15L Peptide Enhanced Bone Graft, versus, autograft in transforminal lumbar interbody fusion for the treatment of degenerative disc disease. P-15L Bone Graft is based on proprietary synthetic small peptide technology, designed to support bone growth through cell attraction, attachment and activation as a substitute for autologous bone.