Cleared Traditional

K014154 - VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09

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

K014154 is an FDA 510(k) clearance for VILEX/DUVAL/ORTHEX CANNULATED BONE SCRE..., manufactured by Vilex, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K014154 · Vilex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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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.

FDA 510(k) Submission Details - K014154

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
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.

HWC Device Classification - Class 2, Special Controls

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 1052
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K014154.
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
K014304 · Triage Medical, Inc. · Mar 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050
K014243 · Triage Medical, Inc. · Mar 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · Smith & Nephew, Inc. · Mar 2002
COAPT SYSTMES ENDOTINE DEVICE
K014153 · Coapt Systems, Inc. · Mar 2002
MITEK BIOCRYL INTERFERENCE SCREWS
K013572 · Mitek Products · Mar 2002
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446 · American Medical Systems, Inc. · Mar 2002
K014154 · VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09
Download PDF Vilex, Inc.