Thoraco-lumbar arthrodesis plate S-2™

bioresorbable polymer1 level

Inion S-2™ anterior lumbar fusion system for graft containment includes specially designed biodegradable plates and screws with radiopaque markers. Inion S-2™ is a US FDA 510(k)-cleared medical device (Class II), manufactured by Inion Oy. The Inion S-2™ Biodegradable Anterior Thoraco-lumbar Fusion System consists of plates and screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. Based on in vitro testing, the implants retain most of their initial strength up to 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The plates and screws contain radiopaque tantalum markers for postoperative radiographic imaging. The Inion S-2™ implants are available in different sizes and are designed for use with customised instrumentation, e.g., the Inion S-2™ drill bits, threading taps, awl, plate holder, drill guides, screw driver, temporary fixation screw, plate templates, and a heating device. The Inion S-2™ Biodegradable Anterior Thoraco-lumbar Fusion System implants are sterile and non-collagenous. Indication This device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing indications.