Subchondral Solutions Receives 510(k) Clearance From FDA
Published: Oct 05, 2017
LOS ANGELES, CA--(Marketwired - September 29, 2017) - Subchondral Solutions, Inc. -- a medical device company-- has just received 510(k) clearance from the Food and Drug Administration (FDA) for its S4 Screw System™. The S4 Screw System™ is a fenestrated cannulated family of screws specifically designed for osteochondral fractures of the joint.
"The S4 Screw System™ represents the first FDA-cleared device on our progressive product platform and allows us to begin commercialization of the suite of products for launch in the U.S.," says Thay Q. Lee, Ph.D. --Chief Scientist for the company.
CEO Derek T. Dee, M.D. adds, "Our proprietary biomechanical implant system offers a new clinical solution for osteochondral fractures of the joint and with our recent 510(k) FDA clearance we are looking ahead to growing our product line -- Our goal is to improve quality of life for the millions of people who suffer from joint pain by early treatment of patients and potentially preventing the progression of joint damage."
About Subchondral Solutions, Inc.
Subchondral Solutions, Inc. is developing a proprietary platform technology to address joint pain and joint damage via biomechanical and bioactive implants. The innovation focuses on biomechanical support for the entire bone-cartilage unit and creation of a healing space for joint restoration.
Up to 27 million Americans suffer annually from cartilage damage in the knee, but most existing treatments do not offer a long-term restorative solution for patients.
The company offers a unique approach to joint damage with a biomechanical, cost-effective, and scalable implant system.