DSM Receives FDA 510(k) Clearance for Dyneema Purity Radiopaque Cerclage Cable

FDA cleared the Dyneema Purity® Radiopaque Cerclage Cable for use in orthopaedic trauma treatments, such as bone and spine fractures. This marks the first clearance for a device fully designed and developed by DSM’s Biomedical Polyethylenes Team.

Purity Radiopaque fiber is reportedly 15 times stronger than steel, with high pliability and flexibility that may help lower the risk of bone damage. The fiber is biocompatible and chemically inert, which can help reduce tissue inflammation, irritation and complications associated with metal allergies.

Source: DSM