# K052623: Imageless Hip Module for the Stealthstation System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Navigation, Inc.
- Decided: Mar 2, 2006 after 160 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021980 (2002). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021980: Hip Module for the Stealthstation System, Medtronic Surgical Navigation Technologies (2002) Summary page 1.

## Most influential descendants
- K133759: Intellijoint Hip (2014), 10 descendants of its own
- K151364: Intellijoint HIP (tm) System (2015), 8 descendants of its own
- K162364: Intellijoint HIP Generation 2A System (2017), 7 descendants of its own
- K171525: Intellijoint HIP Generation 2B System (2017), 3 descendants of its own
- K191507: Intellijoint® Navigation System (2019), 2 descendants of its own

## 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, fluoroscopy images, or digitized landmarks of the anatomy. The Imageless 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/K052623
Methodology: https://510kreport.com/methodology