Cleared Traditional

K043248 - TIGHTROPE SYNDESMOSIS REPAIR KIT

Also marketed or referenced as:
STAINLESS STEEL. MODEL AR-8921DS

K043248 is the FDA 510(k) clearance for TIGHTROPE SYNDESMOSIS REPAIR KIT by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HTN) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K043248 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
85d
Days
Class 2
Risk

K043248 is an FDA 510(k) clearance for the TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS. 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 February 16, 2005 after a review of 85 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 K043248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2004
Decision Date February 16, 2005
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K043248.
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
K061925 · Arthrex, Inc. · Oct 2006
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
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
K023119 · Arthrex, Inc. · Dec 2002
SYNTHES METALLIC SPIKED WASHERS
K013806 · Synthes (Usa) · Feb 2002
SPIKED WASHER
K011583 · Synthes (Usa) · Jan 2002