Cleared Special

Vital Navigation System (K213720) - FDA 510(k) Clearance

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

K213720 · Zimvie (Zimmer Biomet Spine, Inc.) · Orthopedic device
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Jan 2022
Decision
44d
Days
Class 2
Risk

K213720 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 (Zimmer Biomet Spine, Inc.) (Westminister, US). The FDA issued a Cleared decision on January 7, 2022 after a review of 44 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 (Zimmer Biomet Spine, Inc.) devices

Submission Details

510(k) Number K213720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2021
Decision Date January 07, 2022
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
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 K213720.
CoreLink Navigation Instruments
K214059 · Corelink, LLC · Jan 2022
iASSIST Knee System
K213033 · Orthosoft D/B/A Zimmer Cas · Jan 2022
360CAS
K213380 · Kico Knee Innovation Company Pty Limited · Jan 2022
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
K213546 · Blue Ortho · Jan 2022
Integrity Implants Navigated Instruments
K212088 · Integrity Implants, Inc. · Dec 2021
REAL INTELLIGENCE CORI (CORI)
K212537 · Blue Belt Technologies, Inc. · Nov 2021