Manufacturer
Stryker Leibinger GmbH & Co KGQ Guidance System; Mako Spine System;
Stryker Leibinger GmbH & Co KG
Country / Region:Germany (DE)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Device details
FDA 510(k) registration fields
- K number
- K241517
- Device name
- Q Guidance System; Mako Spine System;
- Country / Region
- Germany(DE)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-05-29
- Decision date
- 2024-08-27
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation SystemOther
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
The 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 skull, pelvis or spine can be identified. The system assists in the positioning of instruments for procedures on the pelvis and spine, including: • Screw and Needle Placement in the spine or pelvis • Bone resection in the spine
Intended Use
The 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 skull, pelvis or spine can be identified. The system assists in the positioning of instruments for procedures on the pelvis and spine, including: • Screw and Needle Placement in the spine or pelvis • Bone resection in the spine.
Device Description
The Spine Guidance System is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery on the spine and pelvis. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery. The system is comprised of the Spine Guidance 5.2 Software, Q Guidance System (computer platform), Mako Spine System, navigated accessories/ instruments (e.g., patient/ instrument trackers, pointers), and various system components (e.g., trackers, calibration instruments, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies as well as haptic trajectory guidance to facilitate pedicle preparation and screw placement using Mako Spine System. The Spine Guidance 5.2 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.
Summary parsed at:2026-06-19 05:33:31 UTC
Predicate devices
4—
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Not ingested
Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
Mako Total Knee Application
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
K241517 references 4 predicate/reference devices
Cited as predicate
2Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
Q Pedicle Instruments
2 submissions cite K241517 as a predicate
