Physician Resources
Newly Available, Newly Approved
Am J Orthop. 2007 November;36(11):629
| Small Bone Innovations, Inc. has announced the augmentation of its Elbow Management System with the launch of the rHead™ Lateral Radial Head Implant System and the rHead™ Plating System for internal fixation of proximal radius fractures. The rHead Lateral Implant is a side-loading radial head prosthesis that allows for a minimally invasive approach and exposure in radial head replacement surgery. The head and stem of the implant connect by means of a dove-tail locking mechanism that does not require a set screw. The rHead implant and new plating systems have received 510(k) clearance by the FDA. The rHead Lateral is indicated for treatment of arthritic and traumatic conditions of the radial head. The stem of the rHead Lateral implant is plasma coated with titanium for immediate stability in the canal and optimum osteo-integrating properties. As with SBi’s existing rHead implants, the stem has a 12° curve to match the anatomy of the radius. This stem is available with a 2-mm standard collar or a 6-mm extended collar. A unique feature of the system is the coupling mechanism between the radial head and stem that enables the prosthesis to be implanted sideways to reduce ligament disruption. The new rHead Lateral implant comes with an assembly tool for quick engagement or disengagement of the head and stem. The accompanying impactor tool is configured to ensure precise positioning of the implant by referencing the surrounding anatomy, For more information, contact, Small Bone Innovations, Inc., |
LOW-DOSE X-RAY IMAGER
| Biospace has announced that it has received 510k clearance from the Food and Drug Administration (FDA) to market EOS, a new digital X-ray imager in the United States for 2D imaging use. EOS 2D/3D technology is part of a total solution to orthopedic imaging allowing images to be obtained with a low dose of radiation and is capable of long-length digital imaging, permitting full-body, uninterrupted digital imaging with a single scan. Biospace notes that information submitted to FDA in support of its marketing application demonstrated up to 10 times reduction in dose when compared with commercially available film systems—without compromising image quality. The company points to other features that set EOS apart from traditional X-ray or computed tomography (CT): it captures a full or partial body image; it provides a large reduction in radiation dose; multi-planar (frontal and lateral) images are obtained simultaneously in an upright, weight-bearing position, and the whole-body, standing position imaging it affords is especially useful when one examines spine and joint alignment. EOS’s use of slot-scanning technology eliminates vertical distortion. The simultaneous bi-plane image acquisition (front and side images acquired at the same time) eliminates the need for taking a second view and can save time. To learn more, contact, Biospace |