Cleared Traditional

BONE-LOK HP WASHER (K040250) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040250 · Triage Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
50d
Days
Class 2
Risk

K040250 is an FDA 510(k) clearance for the BONE-LOK HP WASHER. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Triage Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on March 23, 2004 after a review of 50 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 Triage Medical, Inc. devices

Submission Details

510(k) Number K040250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2004
Decision Date March 23, 2004
Days to Decision 50 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 122d · This submission: 50d
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 51
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K040250.
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
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