# K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger
- Decided: Dec 3, 2001 after 130 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
273 later devices descend from it; 10 cite it directly.
0 of 274 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K032117: Stryker Total Performance (TPS) System (2003), 238 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Recalls of this device
- Oct 16, 2017 · Class II · Z-1216-2018: Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker¿ Navigation System becau

## Indications for use
The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images. The Stryker Navigation System- Spine & Fluoroscopy Module supports, but is not limited to the following surgical procedures: Pedicle Screw Placement Navigation Precisely pasitioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones in the upper and lower extremities and long bones. This submission is not intended for total joint replacement procedures.

Source page: https://510kreport.com/device/K012380
Methodology: https://510kreport.com/methodology