Cleared Traditional

K192818 - Vertaplex HV High Viscosity Radiopaque Bone Cement

Also marketed or referenced as:
ES2 Augmentable Spinal System

K192818 is an FDA 510(k) clearance for Vertaplex HV High Viscosity Radiopaque ..., manufactured by Stryker Corporation. The device is a Class 2 Orthopedic device with product code PML cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K192818 · Stryker Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
182d
Days
Class 2
Risk

K192818 is an FDA 510(k) clearance for the Vertaplex HV High Viscosity Radiopaque Bone Cement. Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on March 31, 2020 after a review of 182 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 Stryker Corporation devices

FDA 510(k) Submission Details - K192818

510(k) Number K192818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2019
Decision Date March 31, 2020
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PML Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K192818.
BonOs Inject Bone Cement
K212489 · Neo Medical SA · Oct 2021
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
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
K190526 · CarboFix Orthopedics , Ltd. · Sep 2019
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