Dyneema Purity radiopaque cerclage cable from DSM receives FDA 510(k) clearance for use in orthopaedic trauma

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The US Food and Drug Administration (FDA) has cleared DSM Biomedical’s Dyneema Purity radiopaque cerclage cable for use in orthopaedic trauma treatments, such as the treatment of spine fractures.

The cerclage cable is composed of Dyneema Purity radiopaque fibre, which, according to a press release, is the only the only radiopaque ultra-highmolecular-weight polyethylene (UHMWPE) medical fibre on the global market. Other polymeric cerclage cables available are not radiopaque, so, such cables could offer surgeons the benefit of visualisation during and after surgical intervention. According to DSM, Dyneema Purity is 15 times stonger than steel, but maintains high pliability and increased flexibility. This is intended to help lower the risk of bone damage. The fibre is also biocompatible and chemically inert.

DSM Biomedical used its experience in developing UHMWPE medical fibres as well as its participation in a public-private partnership with Maastricht University Medical Center (The Netherlands) to design this new concept in cerclage cable. 

According to a DSM product specification sheet, the fibre can be used in laminar wires for high performance spinal repair, spinal fusion, disc replacement and inter-spinous devices and for designing devices used in emerging procedures like dynamic stabilisation and other non-fusion applications.

“At MUMC, we have been studying the use of DSM’s Dyneema Purity Radiopaque fibre in cerclage cables as a replacement for metal surgical cables,” says Lodewijk van Rijn, professor and head of Orthopaedic Surgery Department at MUMC. “This FDA clearance, which includes part of our research, will also support our ongoing studies on the development of innovative orthopaedic treatment concepts.” 

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