# K961120: Marker System for Stereotaxic Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Leibinger, Inc.
- Decided: May 10, 1996 after 50 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: 1 generation back to K854886 (1986). 2 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892425: STP Complete Module Set, Leibinger & Fischer, Ltd. (1990) Summary page 2.
- K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 2.

## Most influential descendants
- K982463: Extracranial Radiotherapy System (1998), 8 descendants of its own
- K991336: Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy (1999), 7 descendants of its own
- K100691: Omni V SBRT Positioning System, Model RT-4500 (2010), 6 descendants of its own
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K092192: Waypoint Stereotactic System (2010), 4 descendants of its own

## Indications for use
The Marker System is intended for establishing fixed reference points in patients requiring stereotactic surgery. Examples of situations necessitating stereotaxy could include patients in need of biopsy, resection, lesion generation, implantation of radioisotopes, and small field external beam radiotherapy. The Marker System can be used as an accessory with all currently marketed Howmedica Leibinger® stereotactic systems and can also be used with frameless navigation systems from other manufacturers.

Source page: https://510kreport.com/device/K961120
Methodology: https://510kreport.com/methodology