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Spine Guidance Software, Stryker Q Guidance System

Stryker Leibinger GmbH & Co KG

Country / Region:Germany (DE)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K220593
Device name
Spine Guidance Software, Stryker Q Guidance System
Country / Region
Germany(DE)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2022-03-01
Decision date
2022-05-27
Submission type
Traditional
Technology type
Software Navigation(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

The Stryker Q Guidance System, when used with the Spine Guidance software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the spine, pelvis or skull can be identified. The system assists in the positioning of instruments for procedures on the spine and pelvis, including:
- Screw Placement in the spine or pelvis

Intended Use

The Stryker Q Guidance System, when used with the Spine Guidance software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the spine, pelvis or skull can be identified. The system assists in the positioning of instruments for procedures on the spine and pelvis, including: - Screw Placement in the spine or pelvis.

Device Description

The Stryker Q Guidance System with Spine Guidance 4.0 Software system is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning instruments and locating patient anatomy during spinal surgery. The Q Guidance System with Spine Guidance 4.0 Software system is comprised of a computer platform, Spine Guidance Software, navigated accessories/instruments (e.g., patient/instrument trackers, pointers), and various system components (i.e. Calibration Body, Registration Pointer, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 4.0 Software is dedicated to spine surgical procedures as defined in the indications for use. Required navigated instruments include a patient tracker, an instrument tracker, pointers, etc. An instrument battery is required when a battery powered instrument or calibration device is used. The Spine Guidance 4.0 Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via wireless optical tracking technology. The software provides the functions to perform the indicated navigated spine surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated spine surgical procedures.

Summary parsed at:2026-06-24 04:32:31 UTC

Predicate devices

3

K220593 references 3 predicate/reference devices

Cited as predicate

3
  • Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System

    Stryker Leibinger GmbH & Co KG

  • Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece

    Stryker Leibinger GmbH & Co KG

  • StealthStation S8 Spine Software

    Medtronic Navigation, Inc.

3 submissions cite K220593 as a predicate