Subchondral Solutions Inc. has received 510(k) clearance from the FDA for its S-core osteochondral reconstruction and joint repair platform technology, according to a company press release.
The S-core platform is a hydroxyapatite-coated, bone-preserving, fenestrated and cannulated family of screws, according to the release. It is specifically designed for fixation of osteochondral fractures and other small bone fragments, where screw placement is crucial, such as condylar fractures, patellar fractures, navicular fractures and cancellous bone fragments.
“We are developing a line of products that will address the fundamental issues of joint damage including restoring the biomechanical function of the entire osteochondral unit, as well as creating an effective platform for healing,” orthopedic surgeon and S-core developer Derek T. Dee, MD, said in the release. “Our focus is on generating a platform restorative technology for joint damage using bio-active implants,” he added.