Cleared Traditional

K021791 - VERTE-STACK SPINAL SYSTEM

K021791 is the FDA 510(k) clearance for VERTE-STACK SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K021791 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
87d
Days
Class 2
Risk

K021791 is an FDA 510(k) clearance for the VERTE-STACK SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on August 26, 2002 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K021791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2002
Decision Date August 26, 2002
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K021791.
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
K022143 · Interpore Cross Intl. · Jan 2003
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K023570 · Medtronic Sofamor Danek · Nov 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · Implex Corp. · Aug 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967 · Implex Corp. · Jul 2002
VERTEBRAL SPACER
K011037 · Synthes (Usa) · Jul 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · Implex Corp. · May 2002