[Edaily Reporter KIM JI-WAN ] OSTEONIC Co., Ltd.(226400)announced on the 20th that “Suturepasser,” a surgical tool it developed in-house, has received approval from the Ministry of Food and Drug Safety (MFDS).

The “Suturepasser,” which received approval this time, is a surgical instrument used in sports medicine procedures. Sports medicine products are a product line used for reconstructive surgery in cases of ligament damage caused by sports activities or aging, and they primarily utilize biomaterials.

OSTEONIC Co., Ltd.’s sports medicine products are used in surgeries where an anchor is inserted into the bone, and suture thread is then used to suture or secure the damaged ligament. The “Suturepasser” is the surgical tool used to thread or secure the suture during this procedure. The “Suture Passer” is used to precisely guide the suture thread attached to the anchor through the torn tendon and then pull and tie it tightly to the bone to re-secure or suture the ligament.

The “Suture Passer” recently developed by OSTEONIC Co., Ltd. and approved by the Ministry of Food and Drug Safety was initially developed at the request of its partner, “Zimmer Biomet.”

Development was initiated in response to a request from “Zimmer Biomet,” OSTEONIC Co., Ltd.’s global ODM/OEM partner in the sports medicine business, which expressed a desire to sell the disposable “Suture Passer” as a set with its sports medicine products. This means providing physicians with a packaged solution that allows them to perform surgeries using OSTEONIC Co., Ltd.’s products and surgical instruments.

OSTEONIC Co., Ltd. is currently undergoing the FDA approval process to supply global volumes of the “Suture Passer” to Zimmer Biomet. Approval is expected by the end of this year. With this approval from the Korean Ministry of Food and Drug Safety, the company plans to first launch the package product in Korea; following FDA approval, it expects rapid sales growth as global volumes are added.