FDA Clears KISSloc Suture System From Arthrosurface

Arthrosurface Inc. has won U.S. Food and Drug Administration 510(k) clearance for its KISSloc suture system, a mini plate and suture implant designed to correct 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. The small 1.2 millimeter bone tunnels significantly reduce the stress on the bone caused by larger holes while the low-profile plates distribute the load across a larger area, the company noted in a news release.

Hallux Valgus, which is generally called bunion, is an abnormality of the big toe that occurs from enlargement of the metatarsal head and an abduction of the toe. It is the most common foot deformity with data showing that approximately 23 percent of people aged 18-65 and 35 percent of people older than the age of 65 have developed bunions, the company claimed. Foot surgeons contend that ill-fitting shoes can cause bunions, although a patient’s genetics also may contribute.

“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,” said Carl Hasselman, M.D., of the University of Pittsburgh Medical Center (in Pennsylvania). “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.”

The system is sterile packaged with completely disposable instrumentation that minimizes the risk of infection. Hallux Valgus correction can be attained with one KISSloc construct instead of two separate suture bridges.

The Franklin, Mass.-based firm plans to release the KISSloc suture system in fourth quarter of this year.
Founded in 2002, Arthrosurface designs and distributes orthopedic devices for joint preservation, restoration and resurfacing.