510(k) · Cleared
ClearedImageless Hip Module for the Stealthstation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Mar 2, 2006 as substantially equivalent to K021980 (Medtronic Surgical Navigation Technologies, 2002) after a 160-day review. Its family tree reaches back 1 generation to 2002. 12 later devices descend from it.
- Decided
- Mar 2, 2006
- Review
- 160 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021980 (2002). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK021980 Hip Module for the Stealthstation SystemMedtronic Surgical Navigation Technologies · 2002 · Recalled
- This deviceK052623 Imageless Hip Module for the Stealthstation SystemMedtronic Navigation, Inc. · 2006
- Descendant · cites it directly · 10 of its ownK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
- Descendant · 2 generations on · 8 of its ownK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- Descendant · 4 generations on · 3 of its ownK171525 Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
- Descendant · 5 generations on · 2 of its ownK191507 Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K133759Intellijoint HipIntellijoint Surgical, Inc. · 2014 · cites it directly10descendants
- K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015 · 2 generations on8descendants
- K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017 · 3 generations on7descendants
- K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017 · 4 generations on3descendants
- K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021980 | Hip Module for the Stealthstation System | Medtronic Surgical Navigation Technologies | 2002 | 2 |
| 0 (this device) | K052623 | Imageless Hip Module for the Stealthstation System | Medtronic Navigation, Inc. | 2006 | — |
| +1 | K133759 | Intellijoint Hip | Intellijoint Surgical, Inc. | 2014 | — |
| +2 | K151364 | Intellijoint HIP (tm) System | Intellijoint Surgical, Inc. | 2015 | — |
| +3 | K162364 | Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | 2017 | — |
| +4 | K171525 | Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. | 2017 | — |
| +5 | K191507 | Intellijoint® Navigation System | Intellijoint Surgical, Inc. | 2019 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021980 | Hip Module for the Stealthstation SystemSummary page 1…bstantial Equivalence The Imageless Hip Module for the StealthStation® System is substantially equivalent to the Hip Module for the StealthStation® System (K021980). The only difference between the Hip Module for the StealthStation® System and the Imageless Hip Module for the S… | 2002 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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…
Read the full statement (134 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052623: Imageless Hip Module for the Stealthstation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052623
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026