# K122096: Karl Storz Navigationpanel Unit (Npu) System

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Sep 27, 2012 after 73 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: 2 generations back to K983831 (1999). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014256: Kolibri Igs Systems, Brainlab AG (2002) Summary page 1.

## Most influential descendants
- K161555: KARL STORZ NAV1 Electromagnetic Navigation System (2016), 2 descendants of its own
- K163439: NaviENT (2017), 1 descendant of its own
- K243053: Navient Image Guided Navigation System (ENT) (955-NC-NC) (2025), 0 descendants of its own
- K201174: TruDi Curette (2020), 0 descendants of its own
- K180948: TruDi NAV Suction Instruments (2018), 0 descendants of its own

## Indications for use
The Navigation Panel Unit System (NPU) is an intraoperative image guided localization system that links a freehand probe tracked by a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set. The system is intended to be used as a positioning aid for navigation in ENT surgery, including but not limited to endoscopic surgery. The NPU is indicated for any medical condition in which the use of stereotacti& surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the radiological imaging-based model of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, otologic surgery, and ENT skull base surgery.

Source page: https://510kreport.com/device/K122096
Methodology: https://510kreport.com/methodology