510(k) · Cleared

Cleared

Acumen Image Guided Surgical System

K051724510(k) TraditionalCleared Jul 19, 200522-day reviewClass II21 CFR 882.4560

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

Ebi, L.P. · HAW Neurological Stereotaxic Instrument

Cleared on Jul 19, 2005 as substantially equivalent to K030764 (Z-Kat, Inc., 2003) after a 22-day review. Its family tree reaches back 3 generations to 2000.

Decided: Jul 19, 2005
Review: 22 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K000310 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK000310 Voyager 6.0 Software OptionPhilips Medical Systems (Cleveland), Inc. · 2000
2 generations backK023975 Voyager LinuxZ-Kat, Inc. · 2002
1 generation backK030764 Z-BOXZ-Kat, Inc. · 2003
This deviceK051724 Acumen Image Guided Surgical SystemEbi, L.P. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000310	Voyager 6.0 Software Option	Philips Medical Systems (Cleveland), Inc.	2000	—
−2	K023975	Voyager Linux	Z-Kat, Inc.	2002	—
−1	K030764	Z-BOX	Z-Kat, Inc.	2003	—
0 (this device)	K051724	Acumen Image Guided Surgical System	Ebi, L.P.	2005	—

FIG. 1 — Lineage of K051724, 2000–2005Source: 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.

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

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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
*	K030764	Z-BOX Summary page 1 …tem COMMON NAME: Stereotaxic Instrument CLASSIFICATION NAME: Stereotaxic Instrument CLASSIFICATION #: Class II SUBSTANTIAL EQUIVALENCE CLAIMED TO: Z-Box; Z-Kat, Inc. K030764 PURPOSE OF PREMARKET NOTIFICATION: The Acumen TM Surgical Navigation System is identical to the previously FDA cleared Z-Kat In…	Z-Kat, Inc.	2003	—

Also cleared against K030764: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K030764.

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 Acumen mSurgical Navigation System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The AcumenTh Surgical Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:

* Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

* Orthopedic surgical procedures

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051724 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051724: Acumen Image Guided Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051724

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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