# K031732: Ebi Acumen Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Oct 15, 2003 after 133 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: 6 generations back to K905070 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023975: Voyager Linux, Z-Kat, Inc. (2002) Summary page 1.
- K013025: Modification to Flourolab Plus, Z-Kat, Inc. (2001)
- K030764: Z-BOX, Z-Kat, Inc. (2003) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K031732
Methodology: https://510kreport.com/methodology