Inion receives CE mark for biodegradable spinal fusion system:
This article was originally published in Clinica
Tampere, Finland orthopaedics company Inion has CE marked its Inion S-1 anterior cervical fusion system for sale in the EU. The device, which gained 510(k) clearance in the US in November 2005, consists of biodegradable plates and screws designed to stabilise the vertebrae during cervical spinal fusion procedures when used in conjunction with adjunctive immobilisation. This type of surgery treats a range of spinal conditions including ruptures and displacement of inter-vertebral discs. The S-1 product is made of a polymer which is invisible to X-rays; however, it incorporates a radiographic marker. This facilitates the post-operative evaluation of the implant using X-rays, by allowing the surgeon to confirm the accurate positioning of the device and to assess healing. The CE mark covers an extended indication for the system: double-level fusions, where three vertebrae are fused together.