DeviceClearance

Y-Knotless Flex Anchors— 510(k) K261363

Substantially Equivalent

CONMED Corporation

FDA 510(k) clearance K261363 for Y-Knotless Flex Anchors, Substantially Equivalent on 2026-05-13. Applicant: CONMED Corporation. Device class: 2.

Summary

CONMED's Y-Knotless Flex Anchors are filed under MBI, nondegradable soft tissue fixation fasteners.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).

CONMED filed from Utica, New York. Review took 16 calendar days (April 27 to May 13, 2026).

Clearance details

Applicant
CONMED Corporation
Product code
Product code MBI
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Utica, NY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MBI

view all

More clearances from CONMED Corporation

view all

Adverse events under product code MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.