POTSDAM -- A medical device designed and tested at Clarkson University has received FDA 510(k) pre-market clearance.

This new device, an adjustable-length intramedullary nail (IM nail), was developed jointly by Clarkson Associate Professor Laurel Kuxhaus and former Canton-Potsdam Hospital Orthopedic Surgeon Marty Clark. An IM nail is a device that is used to put broken long bones, like a tibia or femur, back together.

The innovation’s first use case will be in trauma surgery for tibia leg bone fractures and will enable individualized treatment for patients and cost savings for device manufacturers, hospitals, and surgery centers engaged in tibial intramedullary nailing. The new device will add value to the entire supply chain by greatly reducing stock-keeping unit (SKU) count and inventory costs, streamlining inventory management and device delivery logistics, and improving the patient and provider experience through patient-tailored treatment.

Currently, orthopedic surgeons must choose from up to 127 SKUs of differently sized tibial intramedullary nails for their patients, which span multiple diameters and numerous lengths. Manufacturers, hospitals and surgery centers incur significant inventory costs associated with stocking tibial nails. The innovative adjustable length tibial nail greatly reduces the number of SKUs from 127 to only 9 and will allow the surgeon to customize the nail length for the individual patient prior to implantation.

Kuxhaus, who has a long history of studying orthopaedic implants, connected with Clark at a local networking event. Clark approached her about his idea for the IM nail, and the pair began to develop the device with help from Clarkson students.

Clark and Kuxhaus collaborated to design and patent the adjustable length intramedullary nail in the Orthopaedic Biomechanics Laboratory at Clarkson, with support from the Coulter Foundation and Shipley Center for Entrepreneurship at Clarkson University. The promising results of the research and development led to the founding of Adaptable Ortho Innovations LLC with help from Clarkson alumni and company advisors Scott Gucciardi ’90 and Steve Palin ‘90. The company is actively seeking a strategic partnership to facilitate the next phases of commercializing the patented invention.

Learn more about Adaptable Ortho Innovations and the group’s new IM nail by visiting adaptableortho.com.