FDA Clearance for Arthrosurface’s Hallux Valgus Correction System
Arthrosurface, Inc., a developer of novel joint technologies, has received FDA 510(k) clearance for the KISSloc Suture System, a mini plate and suture implant intended for the correction of a Hallux Valgus deformity. The KISSloc Suture System consists of two low profile plates and a self-cinching suture construct that corrects Hallux Valgus by reducing the intramedullary angle between the first and second metatarsal bones.
Hallux Valgus, universally known as a bunion, is an abnormality of the big toe that is highlighted by enlargement of the metatarsal head and an abduction of the toe. It is the most common foot deformity with data showing that approximately 23% of people aged 18-65 and 35% of people over the age of 65 have developed bunions. According to countless foot surgeons, wearing ill-fitting shoes over a long period of time is one of the main causes of bunions, although a patient's genetic material may also contribute.
Recent peer-reviewed publications have reported various second metatarsal stress fractures associated with competitive suture –button fixation of hallux valgus. The objective of the KISSloc Suture System is to eliminate these failures by allowing more accurate bone tunnel placement, utilizing smaller bone tunnels and a more robust suture. These contribute to improving the ease of final implant placement and result in a more consistent repair.
Dr. Carl Hasselman from UPMC in Pittsburgh, PA, recently commented, "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."
The KISSloc Suture System is sterile packaged with completely disposable instrumentation which minimizes the risk of infection. The small 1.2 mm 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. Additionally, Hallux Valgus correction can be achieved with only one KISSloc construct instead of two separate suture bridges, creating an easy to use, cost effective system. Arthrosurface is on track for a commercial release of the KISSloc Suture System in Q4 of this year.