510(k) · Cleared

Cleared

Modification to Self-Drilling Radiographic Markers

K040990510(k) SpecialCleared May 13, 200427-day reviewClass II21 CFR 878.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Walter Lorenz Surgical, Inc. · NEU Marker, Radiographic, Implantable

Cleared on May 13, 2004 as substantially equivalent to K014148 (Walter Lorenz Surgical, Inc., 2002) after a 27-day review. Its family tree reaches back 2 generations to 2001.

Decided: May 13, 2004
Review: 27 days
Class: Class II
Product code: NEU
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K010348 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010348 Tantalum Beads - Radiographic MarkerBiomet, Inc. · 2001
1 generation backK014148 Self-Drilling Radiographic MarkerWalter Lorenz Surgical, Inc. · 2002
This deviceK040990 Modification to Self-Drilling Radiographic MarkersWalter Lorenz Surgical, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010348	Tantalum Beads - Radiographic Marker	Biomet, Inc.	2001	—
−1	K014148	Self-Drilling Radiographic Marker	Walter Lorenz Surgical, Inc.	2002	—
0 (this device)	K040990	Modification to Self-Drilling Radiographic Markers	Walter Lorenz Surgical, Inc.	2004	—

FIG. 1 — Lineage of K040990, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NEU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NEU device

#1 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K014148	Self-Drilling Radiographic Marker Summary page 1 …le radiographic markers. PREDICATE DEVICE The predicate device is the Stainless Steel Self Drilling Radiographic Marker cleared under W. Lorenz 5 10(k) number K014 148 on January 17, 2002. DESCRIPTION OF DEVICE The Self-drilling Radiographic Markers are zirconium bone screws used as rad…	Walter Lorenz Surgical, Inc.	2002	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All NEU devices

NEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NEU

5in 2025

2007high 10 (2024) · low 2 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEU

99in 2025

2007high 267 (2024) · low 46 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NEU

2in 2025

2007high 2 (2024) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NEU

411in 2025

2007high 411 (2025) · low 5 (2007)2025

MAUDE reports naming product code NEU, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	94	0	5
2008	7	107	0	5
2009	4	70	0	30
2010	5	69	0	12
2011	3	145	1	18
2012	3	120	0	54
2013	7	49	0	60
2014	3	48	0	38
2015	7	111	0	120
2016	2	—	0	56
2017	4	115	1	69
2018	8	89	0	66
2019	5	149	0	58
2020	3	169	0	45
2021	3	46	0	82
2022	2	—	1	100
2023	4	136	0	142
2024	10	267	2 (1)	247
2025	5	99	2	411
2026	1	—	2	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040990 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040990: Modification to Self-Drilling Radiographic Markers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040990

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026