Cleared Special

K261363 - Y-Knotless™ Flex Anchors

K261363 is an FDA 510(k) clearance for Y-Knotless Flex Anchors, manufactured by Conmed Corporation. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 16-day FDA review.

K261363 · Conmed Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
16d
Days
Class 2
Risk

K261363 is an FDA 510(k) clearance for the Y-Knotless™ Flex Anchors. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on May 13, 2026 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K261363

510(k) Number K261363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2026
Decision Date May 13, 2026
Days to Decision 16 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 603
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K261363.
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)
K261968 · Smith & Nephew, Inc. · Jul 2026
Arthrex FiberButton
K260018 · Arthrex, Inc. · Jun 2026
Dione PEEK Screw System
K253130 · ZheJiang Decans Medical Devices Co., Ltd. · May 2026
Anchor with Fiber Wire and Disposable Inserter
K253027 · Ortobio S.A. · May 2026
ArthroTAK Tendon Anchor Kit
K252635 · ArthroTAK, LLC · May 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · Tigon Medical · Apr 2026
K261363 · Y-Knotless™ Flex Anchors
Download PDF FDA Summary Conmed Corporation