Cleared Special

Vital™ Navigation System (K233443) - FDA 510(k) Clearance

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

K233443 · Zimvie Spine (Zimmer Biomet Spine, Inc.) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2023
Decision
28d
Days
Class 2
Risk

K233443 is an FDA 510(k) clearance for the Vital™ Navigation System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Zimvie Spine (Zimmer Biomet Spine, Inc.) (Westminister, US). The FDA issued a Cleared decision on November 16, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 K233443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2023
Decision Date November 16, 2023
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K233443.
RIWOtrack Navigation System
K230700 · Fiagon GmbH · Nov 2023
ExactechGPS® Total Ankle Application
K232521 · Blue Ortho · Nov 2023
ROSA Partial Knee System
K232533 · Orthosoft D/B/A Zimmer Cas · Nov 2023
ATEC Posterior Navigated Disc Prep Instruments
K232345 · Alphatec Spine, Inc. · Nov 2023
CoreLink Robotic Navigation Instruments
K231494 · Corelink, LLC · Oct 2023
TMINI™ Miniature Robotic System
K232802 · THINK Surgical, Inc. · Oct 2023