510(k) K250544

Knotilus+ Biocomposite Knotless Anchor by Stryker Endoscopy — Product Code MAI

K250544 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "Knotilus+ Biocomposite Knotless Anchor". The FDA issued a decision of Substantially Equivalent on May 23, 2025. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Stryker Endoscopy has at least 10 other 510(k) clearances on record.