Cleared Special

K253727 - Syndesmosis TightRope PRO

K253727 is an FDA 510(k) clearance for Syndesmosis TightRope PRO, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Special 510(k) pathway after a 28-day FDA review.

K253727 · 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
28d
Days
Class 2
Risk

K253727 is an FDA 510(k) clearance for the Syndesmosis TightRope PRO. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 22, 2025 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K253727

510(k) Number K253727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2025
Decision Date December 22, 2025
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HTN Washer, Bolt Nut

All 92
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K253727.
LARS ACJ
K253115 · Movmedix S.A.S. · Jun 2026
SportLinc Syndesmosis Device
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Synchfix EVT
K251643 · Wright Medical Technology, Inc. (Stryker Corporation) · Oct 2025
RipCord
K251134 · TriMed, Inc. · Jul 2025
Acu-Sinch Knotless Mini
K243624 · Acumed, LLC · Jan 2025
Bolo Button System
K242091 · Fusion Orthopedics · Dec 2024
K253727 · Syndesmosis TightRope PRO
Download PDF FDA Summary Arthrex, Inc.