Manufacturer
Medtronic Navigation, Inc.StealthStation S8 Spine Software
Country / Region:United States (US)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
- K251282
- Device name
- StealthStation S8 Spine Software
- Company
- Medtronic Navigation, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-04-24
- Decision date
- 2025-10-17
- 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 StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures in adult and skeletally mature pediatric (adolescent) patients. Their use 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. This can include the following spinal implant procedures in adult patients, such as: • Pedicle Screw Placement • Iliosacral Screw Placement • Interbody Device Placement This can include the following spinal implant procedures in skeletally mature pediatric (adolescent) patients: • Pedicle Screw Placement 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 StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures in adult and skeletally mature pediatric (adolescent) patients. Their use 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. This can include the following spinal implant procedures in adult patients, such as: • Pedicle Screw Placement • Iliosacral Screw Placement • Interbody Device Placement. This can include the following spinal implant procedures in skeletally mature pediatric (adolescent) patients: • Pedicle Screw Placement.
Device Description
StealthStation S8 Spine Software helps guide surgeons during spine surgical procedures. The subject software works in conjunction with a navigation system, surgical instruments, a referencing system, and computer hardware. Navigation tracks the position of instruments in relation to the surgical anatomy and identifies this position on pre-operative or intraoperative images of the patient. The mouse, keyboard, touchscreen monitor, and footswitch of the StealthStation platforms are used to move through the software workflow. Patient images are displayed by the software from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display on the monitor. The surgeon may also create and store one or more surgical plan trajectories before and during surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory.
Summary parsed at:2026-06-19 05:22:20 UTC
Predicate devices
2—
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Not ingested
Spine Guidance Software, Stryker Q Guidance System
K251282 references 2 predicate/reference devices
Cited as predicate
2Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
2 submissions cite K251282 as a predicate
