Cleared Special

K262369 - AIR+ All-Inside Meniscal Repair Device

Also marketed or referenced as:
AIR+ All-Inside Meniscal Repair Device, Curved Down

K262369 is the FDA 510(k) clearance for AIR+ All-Inside Meniscal Repair Device by Stryker Endoscopy. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 20-day FDA review.

K262369 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
20d
Days
Class 2
Risk

K262369 is an FDA 510(k) clearance for the AIR+ All-Inside Meniscal Repair Device, Curved Up. 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 Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on July 30, 2026 after a review of 20 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 Stryker Endoscopy devices

Submission Details

510(k) Number K262369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2026
Decision Date July 30, 2026
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 390
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K262369.
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
Y-Knotless™ Flex Anchors
K261363 · Conmed Corporation · May 2026
Anchor with Fiber Wire and Disposable Inserter
K253027 · Ortobio S.A. · May 2026
ArthroTAK Tendon Anchor Kit
K252635 · ArthroTAK, LLC · May 2026