# K010427: Lorenz Fiducail Screw

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Mar 15, 2001 after 30 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 K854886 (1986). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961120: Marker System for Stereotaxic Navigation, Howmedica Leibinger, Inc. (1996) Summary page 1.
- K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System, Walter Lorenz Surgical, Inc. (1995) Summary page 1.

## Most influential descendants
- K160385: Precision Screw (2016), 0 descendants of its own

## Indications for use
The Lorenz Fiducial Screw is intended for establishing fixed reference point(s) in patients requiring stereotactic surgery. The Fiducial Screw can be used as an accessory with frameless navigation systems, as appropriate, from other manufacturers.

Source page: https://510kreport.com/device/K010427
Methodology: https://510kreport.com/methodology