# K220593: Spine Guidance Software, Stryker Q Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: May 27, 2022 after 87 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K993239 (2000). 14 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172034: Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap, Stryker Corporation (2017) Summary page 6.
- K162341: Stryker OrthoMap Precision Knee system, Stryker Leibinger GmbH & Co KG (2016) Summary page 6.

## Most influential descendants
- K240662: 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 (2024), 7 descendants of its own
- K241171: Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (2024), 4 descendants of its own
- K241517: Q Guidance System; Mako Spine System; (2024), 2 descendants of its own
- K252871: Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (2026), 1 descendant of its own
- K223767: Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System (2023), 1 descendant of its own

## 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 The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.

Source page: https://510kreport.com/device/K220593
Methodology: https://510kreport.com/methodology