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Vital™ Navigation System

Zimvie Spine (Zimmer Biomet Spine, Inc.)

Country / Region:United States (US)Submission type:Special

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Zimvie Spine (Zimmer Biomet Spine, Inc.)
United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

3
View list →

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K233443
Device name
Vital™ Navigation System
Company
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-10-19
Decision date
2023-11-16
Submission type
Special
Technology type
Software Navigation(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

The Vital Navigation System instruments are used during the preparation and placement of the Vital and Vitality System screws during spinal surgery to precisely locate anatomical structures in either open or minimally invasive procedures. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System.

Intended Use

The Vital Navigation System instruments are used during the preparation and placement of the Vital and Vitality System screws during spinal surgery to precisely locate anatomical structures in either open or minimally invasive procedures.

Device Description

The Vital™ Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. Both combinations are used to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality Screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. The use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.

Summary parsed at:2026-06-19 05:51:00 UTC

Predicate devices

3
  • K133444

    —

    —

    Not ingested

  • K191722

    —

    —

    Not ingested

  • K212245

    Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning

    Brainlab AG

K233443 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K233443 as a predicate