Cleared Traditional

K973309 - VILEX CANNULATED BONE SCREW

K973309 is an FDA 510(k) clearance for VILEX CANNULATED BONE SCREW, 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 135-day FDA review.

K973309 · Vilex, Inc. · Orthopedic device
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Jan 1998
Decision
135d
Days
Class 2
Risk

K973309 is an FDA 510(k) clearance for the VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Vilex, Inc. (Large, US). The FDA issued a Cleared decision on January 16, 1998 after a review of 135 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

FDA 510(k) Submission Details - K973309

510(k) Number K973309 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 03, 1997
Decision Date January 16, 1998
Days to Decision 135 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 122d · This submission: 135d
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 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K973309.
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K974756 · Biodynamic Technologies, Inc. · Mar 1998
MENISCAL REPAIR DEVICE
K974538 · Linvatec Corp. · Mar 1998
BIOSCREW ABSORBABLE INTERFERENCE SREW
K973758 · Linvatec Corp. · Feb 1998
ORTHOPEDIC SCREW SYSTEM
K972217 · Ferguson Medical · Nov 1997
THE CORIFIX LIGAMENT ANCHOR
K973005 · Corin USA · Nov 1997
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
K973586 · Spinal Concepts, Inc. · Nov 1997