# K040990: Modification to Self-Drilling Radiographic Markers

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: May 13, 2004 after 27 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- 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 K010348 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014148: Self-Drilling Radiographic Marker, Walter Lorenz Surgical, Inc. (2002) Summary page 1.

## Indications for use
Self-Drilling Radiographic Markers are used as radiopaque markers and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.

Source page: https://510kreport.com/device/K040990
Methodology: https://510kreport.com/methodology