Cleared Special

K262809 - ArthroTAK Tendon Anchor Kit

K262809 is an FDA 510(k) clearance for ArthroTAK Tendon Anchor Kit, manufactured by ArthroTAK, LLC. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 26-day FDA review.

K262809 · ArthroTAK, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
26d
Days
Class 2
Risk

K262809 is an FDA 510(k) clearance for the ArthroTAK Tendon Anchor Kit. 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 ArthroTAK, LLC (Missoula, US). The FDA issued a Cleared decision on September 2, 2026 after a review of 26 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.

View all ArthroTAK, LLC devices

FDA 510(k) Submission Details - K262809

510(k) Number K262809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2026
Decision Date September 02, 2026
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 Consultant

Greenfield Consulting, LLC
Ken Riordan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 601
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K262809.
Integrity Retractable Implant Inserter (6000127)
K261869 · Anika Therapeutics, Inc. · Sep 2026
Aevumed SUPERCYNCH™ Button System
K253065 · Aevumed, Inc. · Sep 2026
Iconix Knotless T
K262677 · Riverpoint Medical · Aug 2026
Grappler Suture Anchor System
K262047 · Paragon 28, Inc. · Aug 2026
AIR+ All-Inside Meniscal Repair Device, Curved Up
K262369 · Stryker Endoscopy · Jul 2026
Suture Button Repair System
K261770 · Skeletal Dynamics, Inc. · Jul 2026