Cleared Traditional

K003780 - VERTEX RECONSTRUCTION SYSTEM

K003780 is an FDA 510(k) clearance for VERTEX RECONSTRUCTION SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K003780 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Sep 2001
Decision
295d
Days
Class 2
Risk

K003780 is an FDA 510(k) clearance for the VERTEX RECONSTRUCTION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 295 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Medtronic Sofamor Danek, Inc. devices

FDA 510(k) Submission Details - K003780

510(k) Number K003780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2000
Decision Date September 28, 2001
Days to Decision 295 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 122d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 383
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K003780.
XIA SPINAL SYSTEM
K013823 · Howmedica Osteonics Corp. · Dec 2001
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K012516 · Ebi, L.P. · Nov 2001
ISOLA POLYAXIAL WASHER
K013441 · Depuyacromed · Nov 2001
XIA STAINLESS STEEL SYSTEM
K012870 · Howmedica Osteonics Corp. · Sep 2001
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177
K012871 · Interpore Cross Intl. · Sep 2001
TRI-FIX SPINAL FIXATION SYSTEM
K011830 · Endius, Inc. · Jul 2001