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The Inion spinal graft containment plate system, 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.

INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System plates are bioresorbable anterior thoraco-lumbar fusion devices for graft containment (screws and plates). The plates are made of degradable poly(L-lactide-co-D,L-lactide 80:20). Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years. INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System devices provide fixation and are not intended to replace healthy tissues or withstand the stress of full load bearing. The purpose of this submission is a line extension for new sizes.

Inion Spinal Graft Containment System, 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. The device is not intended for load bearing indications.

Inion Spinal Graft Containment System includes plates, meshes and screws which are made of degradable polylactic acid copolymers, P(L/DL)LA. Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The plates and screws include tantalum spheres for postoperative radiographic imaging. The implants are offered in different shapes and sizes suitable for this application. Inion Spinal Graft Containment System implants are provided sterile to the user and are noncollagenous. The shelf life of the device is 3 years.

The INION S-1™ BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.

Inion S-1™ Biodegradable Anterior Cervical Fusion System, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion rigit fixances (10), posterinain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications. Inion S-1 ™ Biodegradable Anterior Cervical Fusion System consist of cervical spinal fusion plates and screws, and is made of resorbable polylactic acid copolymers, P(L/DL)LA 80:20. Based on in vitro testing: Inion S-1 Biodegradable Anterior Cervical Fusion System retain most of it's strength up to 16 weeks and gradually loose it's strength thereafter, and bioresorption takes place within two to four years. Inion S-1 ™ Biodegradable Anterior Cervical Fusion System is provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.