Cleared Traditional

K192214 - CarboClear VBR System

K192214 is the FDA 510(k) clearance for CarboClear VBR System by CarboFix Orthopedics , Ltd.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K192214 · CarboFix Orthopedics , Ltd. · Orthopedic device
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Oct 2019
Decision
57d
Days
Class 2
Risk

K192214 is an FDA 510(k) clearance for the CarboClear VBR System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by CarboFix Orthopedics , Ltd. (Herzeliya, IL). The FDA issued a Cleared decision on October 11, 2019 after a review of 57 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 CarboFix Orthopedics , Ltd. devices

Submission Details

510(k) Number K192214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2019
Decision Date October 11, 2019
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 152
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K192214.
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
K193506 · Nu Vasive, Incorporated · Feb 2020
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MediExpand TL Expandable VBR System
K190349 · Cmf Medicon Surgical, Inc. · Oct 2019
SYNMESH System
K183054 · Depuy Synthes Spine · May 2019
COLOSSEUM Mesh
K190147 · Globus Medical, Inc. · May 2019
PYRAMESH™ Implant System
K183197 · Medtronic Sofamor Danek USA, Inc. · Apr 2019