Cleared Traditional

K180498 - NuVasive Reline Fenestrated Screws

K180498 is the FDA 510(k) clearance for NuVasive Reline Fenestrated Screws by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code PML) cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K180498 · Nu Vasive, Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
275d
Days
Class 2
Risk

K180498 is an FDA 510(k) clearance for the NuVasive Reline Fenestrated Screws, High V+ Bone Cement. Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on November 28, 2018 after a review of 275 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 Nu Vasive, Incorporated devices

Submission Details

510(k) Number K180498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2018
Decision Date November 28, 2018
Days to Decision 275 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
153d slower than avg
Panel avg: 122d · This submission: 275d
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 K180498.
Vertaplex HV High Viscosity Radiopaque Bone Cement
K192818 · Stryker Corporation · Mar 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
FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
K172269 · Globus Medical, Inc. · Mar 2018
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
K171938 · Medtronic · Oct 2017