# K014148: Self-Drilling Radiographic Marker

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Jan 17, 2002 after 30 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: 1 generation back to K010348 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010348: Tantalum Beads - Radiographic Marker, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K040990: Modification to Self-Drilling Radiographic Markers (2004), 0 descendants of its own

## 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/K014148
Methodology: https://510kreport.com/methodology