Cleared Special

K253895 - Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

K253895 is an FDA 510(k) clearance for Arthrex SwiveLock Suture Anchor, manufactured by Arthrex, Inc.. 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.

K253895 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
26d
Days
Class 2
Risk

K253895 is an FDA 510(k) clearance for the Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm. 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 Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 30, 2025 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.

FDA 510(k) Submission Details - K253895

510(k) Number K253895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2025
Decision Date December 30, 2025
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 Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 606
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K253895.
Y-Knotless™ Flex Anchors
K253763 · Conmed Corporation · Jan 2026
Aevumed PROTEKT Suture Anchor
K260004 · Aevumed, Inc. · Jan 2026
QuadLock™ Fixation System
K253618 · Abanza Tecnomed S.L · Jan 2026
Tigon Medical Knotless and Dual Javelin All-Suture Anchors
K252596 · Tigon Medical · Dec 2025
GMReis Suture Anchors
K252664 · GM Dos Reis Industria e Comercio Ltda. · Nov 2025
Arthrex SutureTak Suture Anchor
K252314 · Arthrex, Inc. · Oct 2025
K253895 · Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
Download PDF FDA Summary Arthrex, Inc.