Cleared Special

Vital™ Spinal Fixation System (K240539) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240539 · Zimvie Spine (Zimmer Biomet Spine, Inc.) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2024
Decision
18d
Days
Class 2
Risk

K240539 is an FDA 510(k) clearance for the Vital™ Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Zimvie Spine (Zimmer Biomet Spine, Inc.) (Westminister, US). The FDA issued a Cleared decision on March 15, 2024 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimvie Spine (Zimmer Biomet Spine, Inc.) devices

Submission Details

510(k) Number K240539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2024
Decision Date March 15, 2024
Days to Decision 18 days
Submission Type Special
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
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K240539.
G Surgical Marksman MIS System
K240737 · G Surgical, LLC · Apr 2024
AnyPlus II Spinal Fixation System
K240350 · GS Medical Co., Ltd. · Apr 2024
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
K233951 · Medtronic Sofamor Danek USA, Inc. · Mar 2024
4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
K232607 · Solco Biomedical Copany India Private Limited · Feb 2024
VADER® Pedicle System
K232628 · Icotec AG · Feb 2024
M.U.S.T. Pedicle Screw System - Extension
K234048 · Medacta International S.A. · Feb 2024