Subchondral Solutions Gains FDA Clearance for S-Core Platform

By Julie A. Vetalice

Subchondral Solutions Gains FDA Clearance for S-Core Platform

Subchondral Solutions received FDA 510(k) clearance to market the S-Core™ Core-preserving Osteochondral Reconstruction and Joint Repair Platform Technology.

Subchondral Solutions S-Core

Subchondral Solutions S-Core, implanted

S-Core is reportedly the first FDA-cleared hydroyapatite-coated, bone-preserving, fenestrated and cannulated line of screws specifically designed for osteochondral fractures and minimally invasive joint reconstruction. S-Core can be used in any osteochondral fracture appropriate for the size of the device, including the knee, elbow, hand, foot, ankle, shoulder and hip.

“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,” said Derek T. Dee, M.D., orthopedic surgeon and developer of the device. “Our focus is on generating a platform restorative technology for joint damage using bio-active implants.”

Product Labels: Trauma Hip, Trauma Ankle/Foot/Toe, Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory