510(k) K253763

Y-Knotless™ Flex Anchors by Conmed Corporation — Product Code MBI

K253763 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "Y-Knotless™ Flex Anchors". The FDA issued a decision of Substantially Equivalent on January 29, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Conmed Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2026
Date Received
November 25, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type