Cleared Traditional

K132820 - VILEX ULTIMA EXTERNAL FIXATION SYSTEM W...

K132820 is an FDA 510(k) clearance for VILEX ULTIMA EXTERNAL FIXATION SYSTEM W..., manufactured by Vilex, Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K132820 · Vilex, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2014
Decision
317d
Days
Class 2
Risk

K132820 is an FDA 510(k) clearance for the VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Vilex, Inc. (Lakewood Ranch, US). The FDA issued a Cleared decision on July 23, 2014 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K132820

510(k) Number K132820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2013
Decision Date July 23, 2014
Days to Decision 317 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
195d slower than avg
Panel avg: 122d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 68
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K132820.
Orthopedic Fixation Pin
K191803 · Tinavi (Anhui) Medical Technologies Co., Ltd. · Apr 2020
Temporary Fixation Pins
K192768 · Eisertech, LLC · Dec 2019
SMV Scientific K-Wire and Pins
K182171 · Summit Medventures · Oct 2018
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
K131459 · Aap Implantate AG · Oct 2013
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
K130298 · Biopro, Inc. · Jun 2013
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · Smith & Nephew, Inc. · Jun 2012