Cleared Traditional

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545) - FDA 510(k) Clearance

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

K190545 · Icotec AG · Orthopedic device
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Jun 2019
Decision
108d
Days
Class 2
Risk

K190545 is an FDA 510(k) clearance for the VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on June 20, 2019 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 K190545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date June 20, 2019
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 444
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K190545.
EUROPA Pedicle Screw System
K191757 · MiRus, LLC · Jul 2019
Salvo™ Spine System
K191045 · Spine Wave, Inc. · Jul 2019
LineSider™ Spinal System
K190360 · Integrity Implants, Inc. · Jun 2019
The JASPER Spinal Fixation System II
K190762 · Gbs Commonwealth Co., Ltd. · Jun 2019
NOVA Minimally Invasive System
K182416 · Baui Biotech Co., Ltd. · Jun 2019
AccelFix Spinal Fixation System
K182544 · L & K Biomed Co., Ltd. · May 2019