Cleared Traditional

K023119 - BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B

K023119 is an FDA 510(k) clearance for BI-CORTICAL BIO POST AND WASHER, 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 90-day FDA review.

K023119 · Arthrex, Inc. · Orthopedic device
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Dec 2002
Decision
90d
Days
Class 2
Risk

K023119 is an FDA 510(k) clearance for the BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B. 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 18, 2002 after a review of 90 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 - K023119

510(k) Number K023119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2002
Decision Date December 18, 2002
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K023119.
BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
K043145 · Arthrex, Inc. · Feb 2005
RESOFIX BIOABSORBABLE EXPANSION BOLT
K043411 · Resofix, Inc. · Feb 2005
TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS
K043248 · Arthrex, Inc. · Feb 2005
SYNTHES METALLIC SPIKED WASHERS
K013806 · Synthes (Usa) · Feb 2002
SPIKED WASHER
K011583 · Synthes (Usa) · Jan 2002
CANNULATED SCREW SYSTEM
K003496 · Pioneer Surgical Technology · Feb 2001