Cleared Traditional

K023119 - BI-CORTICAL BIO POST AND WASHER

K023119 is the FDA 510(k) clearance for BI-CORTICAL BIO POST AND WASHER by Arthrex, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 K023119.
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
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