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Spineology Navigation Instruments

Spineology, Inc.

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

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

2

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K213876
Device name
Spineology Navigation Instruments
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2021-12-13
Decision date
2022-08-05
Submission type
Traditional
Technology type
Image Guided Surgery(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

Spineology Navigation Instruments are indicated for use during the preparation and placement of:
• Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ pedicle screws
• Spineology's OptiMesh® Portal Assembly
during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous orthopedic procedures. These instruments are designed for use with the Medtronic StealthStation® Spine System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.

Intended Use

Spineology Navigation Instruments are indicated for use during the preparation and placement of: • Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ pedicle screws • Spineology's OptiMesh® Portal Assembly during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous orthopedic procedures.

Device Description

Spineology Navigation Instruments are non-sterile, reusable surgical instruments that are manufactured from stainless steel and operated manually. Spineology Navigation Instruments for Pedicular Fixation include Awls, Bone Taps, Drills, and Screwdrivers. The navigable instruments are equipped with a dimensional feature that allows connection to Medtronic's NavLock Trackers. A Navigation Adapter is also available with dimensional features that allows the same instruments to connect to Medtronic's SureTrak™ II Universal Trackers. These instruments are compatible with Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and Medtronic's StealthStation® S7 (v2.1.0) and S8 (v1.0.0) Spine System. Spineology Navigation Instruments for Portal Placement include a Dilator, Portal, Tightener, Wrench, and a Portal Surrogate. The navigable instruments are equipped with dimensional features that allow connection to Medtronic's SureTrak II Universal Trackers. These instruments are compatible with Spineology's OptiMesh Expandable Interbody Fusion System for Access Portal Placement and Medtronic's StealthStation® S8 (v1.2.0) Spine System. Spineology Navigation Instruments are intended to be used during the preparation and placement of spinal implants in optically navigated procedures.

Summary parsed at:2026-06-24 04:17:00 UTC

Predicate devices

2

K213876 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K213876 as a predicate