# K012937: Knee Module for the Stealthstation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Surgical Navigation Technologies
- Decided: Jan 25, 2002 after 147 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
280 later devices descend from it; 2 cite it directly.
2 of 281 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) StealthStation® System: named in the summary without a submission number
- (no number) FluoroNav™ Module for the StealthStation® System: named in the summary without a submission number
- (no number) Orthopilot® System: named in the summary without a submission number

## Most influential descendants
- K053610: Abaris (2006), 278 descendants of its own
- K121498: Percunav (2012), 222 descendants of its own
- K132304: Epiq Diagnostic Ultrasound System (2013), 211 descendants of its own
- K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2016), 100 descendants of its own
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own

## Recalls of this device
- Apr 24, 2014 · Class II · Z-1581-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1600-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1582-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1587-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1601-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1591-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1584-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1578-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1580-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1595-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1594-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1593-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1596-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1590-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1589-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1598-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1592-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1585-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1579-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1602-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1583-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1599-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1588-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1597-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1586-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Oct 31, 2003 · Not classified · Z-0231-04: Surgical devices intended for single use were not labeled for single use.

## Indications for use
The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: Spinal Procedures: Cranial biopsies Tumor resections Craniotomies/ Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Spinal implant procedures, such as pedicle screw placement. ENT Procedures: Orthopedic Procedures: Transphenoidal procedures Intranasal procedures Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Source page: https://510kreport.com/device/K012937
Methodology: https://510kreport.com/methodology