Cleared Special

K232755 - Arthrex FiberTape and TigerTape Cerclage Sutures

K232755 is an FDA 510(k) clearance for Arthrex FiberTape and TigerTape Cerclag..., 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.

K232755 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
28d
Days
Class 2
Risk

K232755 is an FDA 510(k) clearance for the Arthrex FiberTape and TigerTape Cerclage Sutures. 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 October 6, 2023 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 - K232755

510(k) Number K232755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2023
Decision Date October 06, 2023
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 K232755.
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K232755 · Arthrex FiberTape and TigerTape Cerclage Sutures
Download PDF FDA Summary Arthrex, Inc.