Cleared Traditional

K061925 - MINI TIGHTROPE REPAIR KIT

K061925 is the FDA 510(k) clearance for MINI TIGHTROPE REPAIR KIT by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HTN) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K061925 · Arthrex, Inc. · Orthopedic device
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Oct 2006
Decision
116d
Days
Class 2
Risk

K061925 is an FDA 510(k) clearance for the MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS. 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 31, 2006 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K061925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2006
Decision Date October 31, 2006
Days to Decision 116 days
Submission Type Traditional
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
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K061925.
CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
K091799 · Zimmer, Inc. · Sep 2009
MINI TIGHTROPE
K090107 · Arthrex, Inc. · Aug 2009
MINI TIGHTROPE FT REPAIR KIT
K071978 · Arthrex, Inc. · Aug 2007
TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD
K052776 · Arthrex, Inc. · Dec 2005
BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
K043145 · Arthrex, Inc. · Feb 2005
TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS
K043248 · Arthrex, Inc. · Feb 2005