US-based joint technologies developer Arthrosurface has secured FDA 510(k) approval for its KISSloc Suture System.
The KISSloc Suture System is a mini plate and suture implant, which is developed for the correction of a Hallux Valgus deformity.
The system includes two low profile plates and a self-cinching suture construct, which corrects Hallux Valgus by reducing the intramedullary angle between the first and second metatarsal bones.
Hallux Valgus, which is generally called bunion, is an abnormality of the big toe that happen due to enlargement of the metatarsal head and an abduction of the toe.
Recently, University of Pittsburgh Medical Center’s Dr. Carl Hasselman said: "When we looked at the shortfalls in the existing designs we knew that if we could reduce the size of the bone tunnels while providing a stronger suture construct, we could improve patient outcomes considerably.
"However, I think the most important feature is how we were able to create a self-cinching suture bridge so surgeons can easily adjust the correction angle on each patient individually," Hasselman added.
KISSloc Suture System noted that system is sterile packaged with completely disposable instrumentation which minimizes the risk of infection.
The small 1.2 mm bone tunnels will decrease the stress on the bone caused by larger holes, while the low profile plates distribute the load across a larger area.
In addition, Hallux Valgus correction can be attained with one KISSloc construct instead of two separate suture bridges.
The company plans for a commercial release of the KISSloc Suture System in fourt quarter of this year.