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Treace Receives FDA 510(k) Clearance for SpeedPlate™ Rapid Compression Implant Technology
PONTE VEDRA, Fla., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company
About this update from Treace Medical Concepts, Inc.
[{"type":"text","content":"PONTE VEDRA, Fla., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of hallux valgus (commonly known as bunions) through its Lapiplasty® 3D Bunion Correction™ Procedure, today announced that its SpeedPlate™ Rapid Compression Implant System (“SpeedPlate™”) has received 510(k) clearance from the FDA to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle. The SpeedPlate™ System was designed for rapid delivery of titanium compression implants, serving as enabling fixation technology with Treace’s new Micro-Lapiplasty® instrumentation which allows the patented Lapiplasty® procedure to be performed through small, 2cm incisions. The SpeedPlate™ implant platform also serves as a versatile addition to the Company’s fixation portfolio, with broad compatibility with conventional Lapiplasty®, Lapiplasty® Mini-Incision™, and Adductoplasty® procedures/systems. “We are pleased to announce 510(k) clearance of our SpeedPlate™ technology. SpeedPlate™ represents an exciting new fixation platform for Treace as we continue to invest in targeted R&D efforts aimed at making our Lapiplasty® therapy less invasive, faster, and easier for surgeons to perform, reinforcing our mission to improve surgical outcomes for bunion patients and advance Lapiplasty® as the standard of care,” said John T. Treace, CEO, Founder, and Board Member. “As with any procedure involving smaller incisions and less tissue dissection, we believe our Micro-Lapiplasty®/SpeedPlate™ offering may translate to even faster patient recovery with less pain and swelling.” The Company anticipates limited release of SpeedPlate™ implants with Micro-Lapiplasty® instrumentation in the first half of 2023 with expanded access in the second half of 2023. About Treace Medical ConceptsTreace Medical Concepts, Inc. is a medical technology company with the goal of advancing the standard of care for the surgical management of bunion and related midfoot deformities. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 65 million Americans, of which Treace estimates 1.1 million are annual surgical candidates. Treace has pioneered and patente...