MedShape said today it won FDA 510(k) clearance for its DynaNail XL TTC fusion system designed for tibiotalocalcaneal fusion surgery.
The DynaNail XL TTC system is designed to better accommodate patients with longer tibial anatomies and treat tibial fractures, the Atlanta-based company said.
The system is available in 260 mm and 300 mm lengths and includes the company’s pseudoelastic nitinol element to reduce stress risers in the bone and lower chances for tibial fractures.
“The recent additions to the DynaNail portfolio demonstrate our continued commitment toward improving upon the success of the company’s flagship product. We have been pleased with the growing adoption of this unique technology by both orthopaedic surgeons and podiatrists and anticipate continued growth with these new offerings,” CEO Kurt Jacobus said in a press release.
The DynaNail was originally introduced in 2012 and the new DynaNail XL is slated for a launch in early 2018, the company said.
In July, MedShape said it inked a deal to divest its ExoShape ACL fixation system properties to ConMed (NSDQ:CNMD) for an undisclosed amount.