Cleared Traditional

KONG-TL VBR System, KONG-C VBR System (K200235) - FDA 510(k) Clearance

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

K200235 · Icotec AG · Orthopedic device
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May 2020
Decision
120d
Days
Class 2
Risk

K200235 is an FDA 510(k) clearance for the KONG-TL VBR System, KONG-C VBR System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Icotec AG (Altstaetten, CH). The FDA issued a Cleared decision on May 29, 2020 after a review of 120 days - within the typical 510(k) review window.

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: 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 K200235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2020
Decision Date May 29, 2020
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 Consultant

MRCA, LLC
Samuel Pollard

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.

Regulatory Peers - MQP Spinal Vertebral Body Replacement Device

All 67
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K200235.
Ascend VBR System, Ascend NanoTec VBR System
K232173 · Alphatec Spine, Inc. · Oct 2023
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
K211892 · Arftx Medical, LLC · Oct 2022
F3D Corpectomy System
K202637 · Corelink, LLC · Dec 2020
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
K193506 · Nu Vasive, Incorporated · Feb 2020
Small VBR™
K192117 · Ulrich GmbH & Co. KG · Nov 2019
MediExpand TL Expandable VBR System
K190349 · Cmf Medicon Surgical, Inc. · Oct 2019