January 12, 2018 | Blake Mossy
Bodycad received a Health Canada medical device license and clearance to sell its Bodycad OnCall cutting guide system, designed for patient-specific restoration of difficult bone resection procedures such as deformity correction and oncology tumor resection. The system utilized 3D rendering of medical images of the patient’s anatomy, and are delivered as a “procedure in a box” with patient-specific implant and instruments needed to perform procedures such as deformity correction and oncology tumor resection.
IlluminOss Medical received 510(k) clearance from the FDA for its Bone Stabilization System for the treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease. The system utilizes the use of a thin-walled PET balloon that is infused with a liquid monomer and delivered into the intramedullary canal of the bone through a minimally invasive small incision to achieve stabilization.
ORTHOReBIRTH received 510(k) clearance from the FDA for its ReBOSSIS biosynthetic bone scaffold, indicated for use in posterolateral spine procedures. The system’s resorbable cottony flexible synthetic bone material is comprised of calcium carbonate, silicate, polyactic acid which is electrospun into microfiber construction. Clinical tests indicated that ReBOSSIS supports cell activation, retention, and proliferation and demonstrated 54 percent compression recovery rate.
PRODUCT INTRODUCTION & UPDATE
FzioMed announced 500,000 units of its Oxiplex system have sold. The system is an absorbable gel applied to neural tissues following spine surgery. Oxiplex aims to create a temporary physical barrier between adjacent tissues and studies indicate that it can reduce leg pain, back pain, and neurologic symptoms.
Kleiner Device Labs launched its KG 1, a disposable single-use bone graft delivery tool indicated for spinal procedures. The device is comprised of a cannula, plunger and detachable funnel, and a bi-portal design to eject graft into both sides of the space while leaving a central void for the fusion cage.
Merete GmbH launched its PeriPlate, a titanium-alloy, single-hole, duo-screw orthopedic locking plate indicated for the fusion of periprosthetic fractures after hip replacements. The system is designed with V-Duo Monoacial/Polyaxial Locking Holes to help reassemble and support bone fragments for natural osteosynthesis in periprosthetic fractures. The PeriPlate allows micromotion so fragments fuse safely while the periosteum stays vascularized.
Ventris Medical launched its Cellesta full line of placental allograft products, indicated for general surgery, wound care, urologic and orthopedic procedures. Cellesta is a minimally manipulated amnion product that is designed to be delivered in both membrane and flowable forms.