510(k) · Cleared

Recalled · 2003

Imageless Knee Module for the Stealthstation System

K030552510(k) SpecialCleared Mar 19, 200326-day reviewClass II21 CFR 882.4560Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Surgical Navigation Technologies · HAW Neurological Stereotaxic Instrument

Cleared on Mar 19, 2003 after a 26-day review. The FDA summary names its predicate without a number. 2 of the 280 devices in its family, counting itself, have a Class I recall. 279 later devices descend from it. It has been recalled once.

Decided: Mar 19, 2003
Review: 26 days
Class: Class II
Product code: HAW
Recalls: 1
Predicates: 0

279 later devices descend from it, 1 citing it directly. 2 of the 280 devices in this family, counting this one, have a Class I recall.

This deviceK030552 Imageless Knee Module for the Stealthstation SystemMedtronic Surgical Navigation Technologies · 2003
Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
Descendant · 2 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
Descendant · 3 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
Descendant · 4 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
Descendant · 4 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled

Showing 5 of 279 descendants. See all descendants

Descendants cleared per year

2006high 30 (2017) · low 0 (2007)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System8 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System8 generations on · 2025

Most influential descendants

Showing 5 of 279 · See all

K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 4 generations on100descendants
K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 4 generations on87descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K030552	Imageless Knee Module for the Stealthstation System	Medtronic Surgical Navigation Technologies	2003	—
+1	K053610	Abaris	Traxtal Technologies, Inc.	2006	3
+2	K121498	Percunav	Philips Health Care	2012	—
+3	K132304	Epiq Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2013	36
+4	K160807	EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System…	Philips Ultrasound, Inc.	2016	33
+4	K133833	Nuvis Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2014	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	2	0
2010	1	0
2011	1	0
2012	3	0
2013	4	0
2014	8	0
2015	16	0
2016	16	0
2017	30	0
2018	19	0
2019	16	0
2020	27	0
2021	24	0
2022	23	0
2023	18	0
2024	19	0
2025	28	2
2026	22	0

FIG. 1 — Lineage of K030552, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have a Class I recall. 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	—	StealthStation System Named without a submission number			—

What descends from it? (279)

See all 279

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053610	Abaris	Traxtal Technologies, Inc.	2006	278

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 31, 2003	Not classified	Z-0231-04	Other	Surgical devices intended for single use were not labeled for single use.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K053610 (Traxtal Technologies, Inc., 2006) has gone furthest, with 278 descendants of its own.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAW

9in 2025

2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007high 238 (2014) · low 66 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HAW

2in 2025

2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007high 6,062 (2019) · low 49 (2007)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 indications for use for the StealthStation System Imageless Knee Software Module is identical to the StealthStation System indications for use. The indications for use are as follows: 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…

Read the full statement (223 words)

The indications for use for the StealthStation System Imageless Knee Software Module is identical to the StealthStation System indications for use. The indications for use are as follows:

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:

Cranial Biopsies

Tumor Resections

Craniotomies/ Craniectomies

Skull Base procedures

Thalamotomies/Pallidotomies

Pituitary Tumor Removal

CSF Leak Repair

Pediatric Catheter Shunt Placement

General Catheter Shunt Placement

ENT Procedures:

Transphenoidal Procedures

Intranasal Procedures

Orbital Nerve 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

Spinal Procedures:

Spinal Implant Procedures, such as Pedicle Screw Placement

Orthopedic Procedures:

Total Knee Arthroplasty (Primary and Revision)

Unicompartmental Knee Arthroplasty

Minimally Invasive Orthopedic Procedures

Total Hip Replacement (Primary and Revision)

Tumor Resection and Bone/Joint Reconstruction

Femoral Revision

Placement of Iliosacral Screws

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/K030552 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030552: Imageless Knee Module for the Stealthstation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030552

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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