Cleared Traditional

K200596 - G21 Cement, VADER® Pedicle System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200596 · Icotec AG · Orthopedic device
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Oct 2020
Decision
221d
Days
Class 2
Risk

K200596 is an FDA 510(k) clearance for the G21 Cement, VADER® Pedicle System. Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on October 13, 2020 after a review of 221 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Icotec AG devices

Submission Details

510(k) Number K200596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2020
Decision Date October 13, 2020
Days to Decision 221 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
99d slower than avg
Panel avg: 122d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PML Bone Cement, Posterior Screw Augmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
Definition The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.
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 - PML Bone Cement, Posterior Screw Augmentation

All 17
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K200596.
OLYMPIC Posterior Spinal Fixation System
K252885 · Astura Medical · Jan 2026
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
K241034 · Medacta International S.A. · Jun 2024
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
K231809 · Ulrich Medical USA · Oct 2023
PERLA® TL System
K230774 · Spineart · Jun 2023
VADER® Pedicle System, G21 Cement
K222789 · Icotec AG · Jan 2023
Invictus® Bone Cement, Invictus Spinal Fixation System
K221926 · Alphatec Spine, Inc. · Dec 2022