Cleared Traditional

K052196 - VILEX X-FIX

K052196 is an FDA 510(k) clearance for VILEX X-FIX, manufactured by Vilex, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K052196 · Vilex, Inc. · Orthopedic device
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Nov 2005
Decision
103d
Days
Class 2
Risk

K052196 is an FDA 510(k) clearance for the VILEX X-FIX. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Vilex, Inc. (Pleasant Hills, US). The FDA issued a Cleared decision on November 22, 2005 after a review of 103 days - within the typical 510(k) review window.

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: 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 - K052196

510(k) Number K052196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2005
Decision Date November 22, 2005
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 313
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K052196.
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K053472 · Howmedica Osteonics Corp. · Jan 2006
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K053051 · Vanguard Medical Concepts, Inc. · Dec 2005
HOFFMANN II ROD TO WIRE COUPLING
K053349 · Howmedica Osteonics Corp. · Dec 2005
HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
K053038 · Howmedica Osteonics Corp. · Nov 2005
EBI DYNAFIX VISION FOOTPLATE SYSTEM
K052239 · Ebi, L.P. · Sep 2005
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K051616 · Vanguard Medical Concepts, Inc. · Sep 2005