510(k) · Cleared
ClearedEbi Acumen Surgical Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · HAW Neurological Stereotaxic Instrument
Cleared on Oct 15, 2003 as substantially equivalent to K023975 (Z-Kat, Inc., 2002) and 2 other predicates after a 133-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Oct 15, 2003
- Review
- 133 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K905070 (1991). 16 ancestors in all, the oldest K861692 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 5 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 4 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 3 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 2 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 1 generation backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- This deviceK031732 Ebi Acumen Surgical Navigation SystemEbi, L.P. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −5 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −4 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −3 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −2 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −1 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| 0 (this device) | K031732 | Ebi Acumen Surgical Navigation System | Ebi, L.P. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K023975 | Voyager LinuxSummary page 1…me: Stereotaxic Instrument (2 1CFR 882.4560) 3. Predicate or legally marketed* devices that are substantially equivalent: Voyager Linux (K023975) FluroLab Plus (KO13025) Z-BOX (K030764) 4. Description of the… | 2002 |
| * | K013025 | Modification to Flourolab Plus | 2001 |
| * | K030764 | Z-BOXSummary page 1…stantially equivalent: Voyager Linux (K023975) FluroLab Plus (KO13025) Z-BOX (K030764) 4. Description of the device: The EBI@Acumen Surgical Navigation System includes general instrumentation that is utilized wi… | 2003 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 4 other devices also cite its predicate K023975.
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 EBI® Acumen™ Surgical Navigation System is intended to assist the surgeon in accurately locating anatomical structures during open or percutaneous orthopedic surgical procedures. The EBI® Acumen™ Surgical Navigation System is indicated for use in spine and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031732: Ebi Acumen Surgical Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031732
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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