Cleared Traditional

K133275 - MINI TIGHTROPE

K133275 is an FDA 510(k) clearance for MINI TIGHTROPE, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K133275 · Arthrex, Inc. · Orthopedic device
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Jan 2014
Decision
98d
Days
Class 2
Risk

K133275 is an FDA 510(k) clearance for the MINI TIGHTROPE. 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 January 30, 2014 after a review of 98 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

FDA 510(k) Submission Details - K133275

510(k) Number K133275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2013
Decision Date January 30, 2014
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 86
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K133275.
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K140328 · Arthrex, Inc. · Mar 2014
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K133858 · Dallen Medical, Inc. · Feb 2014
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
K132733 · Orthohelix Surgical Designs, Inc. · Jan 2014
TENSYN BAND
K131850 · Dallen Medical, Inc. · Nov 2013
BIOPRO - INFINITY PLATE ANCHOR SYSTEM
K132510 · Biopro, Inc. · Oct 2013