Cleared Traditional

K190526 - High V+ Bone Cement

K190526 is the FDA 510(k) clearance for High V+ Bone Cement by CarboFix Orthopedics , Ltd.. It is a Class 2 Orthopedic device (product code PML) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K190526 · CarboFix Orthopedics , Ltd. · Orthopedic device
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Sep 2019
Decision
199d
Days
Class 2
Risk

K190526 is an FDA 510(k) clearance for the High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws. Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by CarboFix Orthopedics , Ltd. (Herzeliya, IL). The FDA issued a Cleared decision on September 19, 2019 after a review of 199 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 CarboFix Orthopedics , Ltd. devices

Submission Details

510(k) Number K190526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date September 19, 2019
Days to Decision 199 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
77d slower than avg
Panel avg: 122d · This submission: 199d
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 16
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K190526.
G21 Cement, VADER® Pedicle System
K200596 · Icotec AG · Oct 2020
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
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
K191148 · Medtronic Sofamor Danek USA, Inc. · Sep 2019
NuVasive Reline Fenestrated Screws, High V+ Bone Cement
K180498 · Nu Vasive, Incorporated · Nov 2018
FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
K172269 · Globus Medical, Inc. · Mar 2018