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Vital Navigation System

by Zimmer Biomet Spine, Inc. 510(k)

Active United States

510(k) K191722

Overview

The Vital Navigation System is a surgical navigation device classified as a spinal surgical instrument. It assists surgeons in accurately locating anatomical structures during spinal procedures, particularly for the placement of screws such as those used in the Vital and Vitality systems. Designed for precision, it integrates with intraoperative imaging to enhance spatial awareness and reduce operative errors in open or minimally invasive surgeries.

This system is supplied sterile and intended for single-use in spinal surgeries. It is regulated under FDA 510(k) clearance (K191722) and falls under the Orthopedic category (OLO). The device is manufactured by Zimmer Biomet Spine, Inc., and its use is supported by surgical technique guides. No additional regulatory markings beyond the FDA clearance are referenced in the available data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK191722 Date2 Dec 2019ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Vital Navigation System used for?

    The Vital Navigation System is designed to assist surgeons in accurately locating anatomical structures during spinal procedures. It is particularly useful for guiding the precise placement of screws, such as those used in the Zimmer Biomet Spine Vital and Vitality systems. By integrating with intraoperative imaging, it improves spatial awareness and helps reduce operative errors in both open and minimally invasive surgeries.

  • Is the Vital Navigation System supplied sterile and for single-use?

    Yes, the Vital Navigation System is supplied sterile and is intended for single-use only. This ensures optimal hygiene and safety during spinal surgeries, minimizing the risk of contamination or cross-infection.

  • What regulatory clearance does the Vital Navigation System have?

    The Vital Navigation System holds FDA 510(k) clearance under the classification K191722. It is categorized under the Orthopedic product code (OLO) and was determined to be substantially equivalent to a predicate device by the FDA’s Orthopaedic Devices Panel.

  • Does the system require additional tools or software for use?

    The Vital Navigation System integrates with intraoperative imaging systems to provide navigation capabilities. While the device itself is standalone in terms of hardware, its functionality relies on compatibility with existing surgical imaging platforms. Zimmer Biomet Spine provides surgical technique guides to support its use.

  • What types of spinal surgeries is the Vital Navigation System compatible with?

    The Vital Navigation System is compatible with both open and minimally invasive spinal surgeries. Its precision navigation aids in critical procedures where accurate screw placement is essential, such as those involving the Vital or Vitality systems.