Cleared Special

K260004 - Aevumed PROTEKT Suture Anchor

K260004 is the FDA 510(k) clearance for Aevumed PROTEKT Suture Anchor by Aevumed, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 26-day FDA review.

K260004 · Aevumed, Inc. · Orthopedic device
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Jan 2026
Decision
26d
Days
Class 2
Risk

K260004 is an FDA 510(k) clearance for the Aevumed PROTEKT Suture Anchor. 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 Aevumed, Inc. (Malvern, US). The FDA issued a Cleared decision on January 28, 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 Aevumed, Inc. devices

Submission Details

510(k) Number K260004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2026
Decision Date January 28, 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.

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 412
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K260004.
Arthrex Nano FiberTak Suture Anchor
K254229 · Arthrex, Inc. · Mar 2026
LigaMend
K253695 · Riverpoint Medical, LLC · Feb 2026
Y-Knotless™ Flex Anchors
K253763 · Conmed Corporation · Jan 2026
QuadLock™ Fixation System
K253618 · Abanza Tecnomed S.L · Jan 2026
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
K253895 · Arthrex, Inc. · Dec 2025
Tigon Medical Knotless and Dual Javelin All-Suture Anchors
K252596 · Tigon Medical · Dec 2025