Osteonic Receives Approval for 'Suturepasser' Sports Medicine Surgical Tool... Accelerates Supply Through Zimmer Biomet
Osteonic, a company specializing in orthopedic implants, announced on the 20th that its self-developed sports medicine surgical tool, ‘Suturepasser,’ has received product approval from the Ministry of Food and Drug Safety.
Suturepasser is a medical device used in sports medicine surgeries to reconstruct ligaments damaged by sports activities or aging. Sports medicine products typically utilize biomaterials to restore ligaments.
Osteonic’s sports medicine product is used by inserting an anchor into the bone and then using a suture thread to repair or secure the damaged ligament. During this process, the Suturepasser is a surgical tool that precisely guides the suture thread between the damaged tendons and ensures it is pulled tight and fixed closely to the bone.
This product was developed at the request of Osteonic’s global partner, Zimmer Biomet. As Osteonic’s global ODM and OEM partner for sports medicine, Zimmer Biomet wanted to supply sports medicine devices together with disposable Suturepassers as a single package, prompting the development of the product to meet these requirements.
With this, medical professionals can now conduct surgeries using Osteonic’s sports medicine products and Suturepasser together as a package.
Osteonic is currently pursuing approval from the U.S. Food and Drug Administration (FDA) for global supply through Zimmer Biomet. The company expects to obtain FDA approval by the end of this year.
The company plans to begin selling the package product in the domestic market first following this approval from the Ministry of Food and Drug Safety. Once the FDA approval is obtained, global supply through Zimmer Biomet is expected to accelerate, with related sales anticipated to grow rapidly.
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This approval from the Ministry of Food and Drug Safety is expected to serve as a catalyst for Osteonic to fully implement its package strategy, combining sports medicine products and surgical tools in partnership with Zimmer Biomet.
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