Cleared Traditional

K192818 - Vertaplex HV High Viscosity Radiopaque ...

Also marketed or referenced as:
ES2 Augmentable Spinal System

K192818 is the FDA 510(k) clearance for Vertaplex HV High Viscosity Radiopaque ... by Stryker Corporation. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 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