Orthopaedic device company MedShape Inc disclosed on Tuesday the receipt of clearance from the US Food and Drug Administration (FDA) 510(k) for the DynaNail XL TTC Fusion System for use by both orthopaedic surgeons and podiatrists in tibiotalocalcaneal (TTC) fusion surgery.

With expected launch in early 2018, the DynaNail XL is available in 260mm and 300mm lengths, thus expanding the product's use to patients with longer tibial anatomies or who have undergone prior failed fusion procedures using an intramedullary nail (IM) nail.

The company said the DynaNail XL was developed for an IM nail that better accommodates longer patient tibial anatomies or when tibial fractures are present. Its longer length in combination with DynaNail's pseudoelastic NiTiNOL Element could help reduce stress risers in the bone, consequently lowering the chance for tibial fractures.

Like the original 220mm version, the DynaNail XL features an internal NiTiNOL Compressive Element that maintains post-operative compression for up to 6 mm of bone resorption. The DynaNail Compressive Element allows effective load sharing across the bone due to its axial compliance during weight-bearing, said the company.

To date, the DynaNail has demonstrated clinical success in revision TTC surgeries and in patients with large bony defects or who are diabetic, concluded the company.