Cleared Traditional

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

Class II Orthopedic device cleared through predicate-based substantial equivalence.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 122d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Musculosketal Clinical Regulatory Affairs
Justin Eggleton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02087267 Completed Observational

Lumbar Fusion With The Icotec CF/PEEK Pedicle System In Combination With The Icotec CF/PEEK TLIF Cage ETurn™

94
Patients (actual)
6
Sites
Condition studied Degeneration of Lumbar Intervertebral Disc; Degenerative Spondylolisthesis
Eligibility All sexes · 18 Years+
Principal investigator Marcus Eif, MD
Sponsor Sitona AG
Started 2014-03-01 → Primary completion 2021-12-01 → Completed 2022-12-01
Primary outcome
Overall fusion rate
Secondary outcome
Rate of pedicle system implant failures
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PML Bone Cement, Posterior Screw Augmentation

All 14
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K200596.
Invictus® Bone Cement, Invictus Spinal Fixation System
K221926 · Alphatec Spine, Inc. · Dec 2022
BonOs® Inject Bone Cement
K222256 · Neo Medical SA · Aug 2022
BonOs Inject Bone Cement
K212489 · Neo Medical SA · Oct 2021
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement
K201362 · Medtronic · Aug 2020
Vertaplex HV High Viscosity Radiopaque Bone Cement
K192818 · Stryker Corporation · Mar 2020
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
K190526 · CarboFix Orthopedics , Ltd. · Sep 2019