Cleared Special

K263461 - Tendon Anchor

K263461 is an FDA 510(k) clearance for Tendon Anchor, manufactured by Smith & Nephew, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 29-day FDA review.

K263461 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
29d
Days
Class 2
Risk

K263461 is an FDA 510(k) clearance for the Tendon Anchor. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on October 27, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device 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 - K263461

510(k) Number K263461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2026
Decision Date October 27, 2026
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 284
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K263461.
easyEndo™ E-Lite Single Use Powered Endoscopic Staplers
K254291 · Ezisurg Medical Co., Ltd. · Sep 2026
ETHICON™ Circular Stapler (CDH21mm)
K260196 · Ethicon Endo-Surgery, LLC · May 2026
Tri-staple 2.0™ Reloads
K253657 · Covidien (Part of Medtronic) · Apr 2026
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C)
K252739 · Ethicon Endo-Surgery, LLC · Dec 2025
ETHICON 4000 60mm Compact Stapler (EC3D60C)
K250835 · Ethicon Endo-Surgery, LLC · May 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
K243276 · Ethicon Endo-Surgery, LLC · Feb 2025
K263461 · Tendon Anchor
Download PDF FDA Summary Smith & Nephew, Inc.