510(k) K243665

Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) by ZheJiang Decans Medical Devices Co., Ltd. — Product Code MBI

K243665 is an FDA 510(k) premarket notification submitted by ZheJiang Decans Medical Devices Co., Ltd. for the device "Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)". The FDA issued a decision of Substantially Equivalent on January 31, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. ZheJiang Decans Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.