# K021980: Hip Module for the Stealthstation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Surgical Navigation Technologies
- Decided: Nov 19, 2002 after 155 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
355 later devices descend from it; 4 cite it directly.
2 of 356 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) BrainLAB VectorVision Hip: named in the summary without a submission number
- (no number) Stryker Navigation System - Spine & Fluoroscopy Module: 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
- Nov 3, 2009 · Not classified · Z-0923-2010: Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed.
- 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. The Hip Module for the Stealthstation is intended to precisely position instruments and implants in example procedures such as but not limited to: Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision) Tumor Resection and Bone/Joint Reconstruction Placement of Iliosacral Screws Femoral Revision Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

Source page: https://510kreport.com/device/K021980
Methodology: https://510kreport.com/methodology