Cleared Traditional

K991197 - VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW

K991197 is an FDA 510(k) clearance for VILEX/DUVAL/ORTHEX 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 19-day FDA review.

K991197 · Vilex, Inc. · Orthopedic device
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Apr 1999
Decision
19d
Days
Class 2
Risk

K991197 is an FDA 510(k) clearance for the VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S3.... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Vilex, Inc. (Jefferson Hills, US). The FDA issued a Cleared decision on April 26, 1999 after a review of 19 days - a notably fast clearance cycle.

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: 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 Vilex, Inc. devices

FDA 510(k) Submission Details - K991197

510(k) Number K991197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date April 26, 1999
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
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 K991197.
BOLD SCREW
K990622 · New Deal, S.A. · Apr 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776 · Aap Implantate AG · Apr 1999
STAYFUSE
K990804 · Pioneer Surgical Technology · Apr 1999
ULTIMAX CORTICAL BONE SCREWS
K990513 · Biodynamic Technologies, Inc. · Mar 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
K984209 · Biomet, Inc. · Feb 1999
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
K983592 · Sulzer Orthopedics, Inc. · Jan 1999