# K051724: Acumen Image Guided Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jul 19, 2005 after 22 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: 3 generations back to K000310 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030764: Z-BOX, Z-Kat, Inc. (2003) Summary page 1.

## Indications for use
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

Source page: https://510kreport.com/device/K051724
Methodology: https://510kreport.com/methodology