Manufacturer
Stryker Leibinger GmbH & Co KGSpine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
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
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253623
- Device name
- Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
- Country / Region
- Germany(DE)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-11-18
- Decision date
- 2026-02-19
- Submission type
- Traditional
- Technology type
- Stereotactic Surgery(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 5 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 orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic 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 surgical procedures on the spine and pelvis, including: - Screw and Needle Placement in the spine or pelvis - Bone resection in the spine - Interbody device placement in the lumbar spine (adults only)
Intended Use
The Q Guidance System, when used with the Spine Guidance 5 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 orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic 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 surgical procedures on the spine and pelvis, including: Screw and Needle Placement in the spine or pelvis, Bone resection in the spine, Interbody device placement in the lumbar spine (adults only).
Device Description
The Spine Guidance 5.4 System is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. 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 5.4 Software, the Q Guidance System (computer platform), Mako Spine System, navigated accessories / instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adapters, patient / instrument trackers, 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 5.4 Software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices. The Spine Guidance 5.4 Software includes all the existing features from the Spine Guidance 5.3 Software described in K252871. Updates to the software include the integration of the Q Drill Tracker as a new system component, ability to navigate the Maestro Air Motor, integration of additional burs, and now allows the NavLock Adapter to be used with two additional trackers.
Summary parsed at:2026-06-19 04:30:49 UTC
Predicate devices
2—
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Not ingested
Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
K253623 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K253623 as a predicate
