Cleared Traditional

K052776 - TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE

K052776 is the FDA 510(k) clearance for TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HTN) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K052776 · Arthrex, Inc. · Orthopedic device
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Dec 2005
Decision
71d
Days
Class 2
Risk

K052776 is an FDA 510(k) clearance for the TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS A.... 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 13, 2005 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K052776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date December 13, 2005
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 66
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K052776.
MINI TIGHTROPE
K090107 · Arthrex, Inc. · Aug 2009
MINI TIGHTROPE FT REPAIR KIT
K071978 · Arthrex, Inc. · Aug 2007
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
K061925 · Arthrex, Inc. · Oct 2006
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
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
K023119 · Arthrex, Inc. · Dec 2002