Cleared Traditional

VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09 (K014154) - FDA 510(k) Clearance

Also marketed or referenced as:
VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00

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

K014154 · Vilex, Inc. · Orthopedic device
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Mar 2002
Decision
90d
Days
Class 2
Risk

K014154 is an FDA 510(k) clearance for the VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Vilex, Inc. (Pleasant Hills, US). The FDA issued a Cleared decision on March 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 888.3040 - 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 Vilex, Inc. devices

Submission Details

510(k) Number K014154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2001
Decision Date March 18, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 402
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K014154.
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832 · Biomet, Inc. · Jun 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · Arthrex, Inc. · Apr 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · Smith & Nephew, Inc. · Mar 2002
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · United States Surgical, A Division of Tyco Healthc · Dec 2001
REUNITE FUSION SCREW
K011451 · Biomet, Inc. · Dec 2001
SOFT TISSUE SCREW AND WASHER
K012572 · Biomet, Inc. · Dec 2001