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.
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Minimally invasive joint reconstruction product line
addresses fundamental issue of joint damage
HUNTINGTON BEACH, Calif., (July 24, 2020) -- Subchondral Solutions, Inc., a medical device company based in Huntington Beach, Calif., has received 510(k) Food and Drug Administration (FDA) clearance for its S-Core™ core-preserving Osteochondral Reconstruction System. S-Core™ is the first and only hydroxyapatite-coated (HA), bone-preserving, fenestrated and cannulated family of implants specifically designed for minimally invasive joint reconstruction, with FDA clearance.
“This regulatory clearance has enabled the company to begin commercialization of its suite of products in the U.S.,” says Derek T. Dee, M.D., orthopedic surgeon and device developer who has successfully performed multiple procedures using the product. “I find osteochondral damage in many of my sports medicine procedures, and until now did not have the technology to repair them.”
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. The S-Core™ technology is indicated for minimally invasive joint reconstruction and fixation of small bone fragments, such as osteochondral fragments and cancellous fragments including simple metaphyseal fractures; condylar fractures; osteochondritis dissecans; areas where accurate screw placement is vital; patellar fractures, navicular fractures, intra-articular fractures and osteochondral fixation and fractures, as well as ligament fixation.
“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,” says Dr. Dee. “Our focus is on developing a platform of restorative technology for joint damage using bio-active implants.”
About Subchondral Solutions, Inc.
Subchondral Solutions is developing a proprietary platform technology and is committed to advancing the treatment of joint damage by addressing the source of the problem with a biomechanical, efficient, cost-effective scalable system. As many as 27 million Americans suffer from joint damage in the knee annually; the majority of existing treatments are palliative and do not creative a long-term solution for patients.
Subchondral Solutions has an extensive worldwide patent portfolio with issued and published intellectual property reflecting this innovative approach to the treatment of joint damage. A family of devices for the entire spectrum of joint damage is reflected in the patent roadmap.
Tom Kinder, CEO, Subchondral Solutions
By Julie A. Vetalice
Subchondral Solutions received FDA 510(k) clearance to market the fenestrated, cannulated S4 Screw System™ to treat osteochondral fractures.
S4 is the company's first FDA-cleared device in its platform that will address joint pain and damage with biomechanical and bioactive implants. The approach focuses on early biomechanical support for the entire bone/cartilage unit. Subchondral Solutions was established in California in 2014.
Source: Subchondral Solutions, Inc.
Read the full article at Orthoworld.com
LOS ANGELES, CA--(Marketwired - Sep 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.
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Derek T. Dee
Read the full article at GlobeNewswire