Cleared Traditional

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (K190526) - FDA 510(k) Clearance

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

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 17
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K190526.
OLYMPIC Posterior Spinal Fixation System
K252885 · Astura Medical · Jan 2026
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
K241034 · Medacta International S.A. · Jun 2024
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
K231809 · Ulrich Medical USA · Oct 2023
PERLA® TL System
K230774 · Spineart · Jun 2023
VADER® Pedicle System, G21 Cement
K222789 · Icotec AG · Jan 2023
Invictus® Bone Cement, Invictus Spinal Fixation System
K221926 · Alphatec Spine, Inc. · Dec 2022