Subchondral Solutions receives FDA 510(k) clearance for implant to treat bone edema
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Subchondral Solutions Inc. has announced FDA 501(k) clearance for its S-Core implant platform, according to a press release.
The S-Core implant is indicated for the treatment of bone edema in the subchondral bone, according to the release. The implant, which is coated with hydroxyapatite to maximize bone and biologic healing, can also be used as a suture anchor and attachment for soft tissue allografts.
“The recent clearance, with expanded indications, will allow Subchondral Solutions to broaden our marketing efforts and messaging,” Thomas Kinder, CEO of Subchondral Solutions, said in the release. “Our S-Core device provides surgeons in foot and ankle, upper extremities and sports medicine unparalleled options to best serve their patients,” Kinder added.
“The S-Core implant platform may be used as a standalone screw for the fixation of trabecular fractures, fusion and osteotomies,” Jordan Peana, vice president of sales at Subchondral Solutions, said in the release. “The S-Core implant system may also be used with our S-Fibre suture when a suture anchor is needed for the attachment of soft tissue to bone.”