510(k) · Cleared

Cleared

Self-Drilling Radiographic Marker

K014148510(k) SpecialCleared Jan 17, 200230-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 Jan 17, 2002 as substantially equivalent to K010348 (Biomet, Inc., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Jan 17, 2002
Review: 30 days
Class: Class II
Product code: NEU
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010348 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010348 Tantalum Beads - Radiographic MarkerBiomet, Inc. · 2001
This deviceK014148 Self-Drilling Radiographic MarkerWalter Lorenz Surgical, Inc. · 2002
Descendant · cites it directly · 0 of its ownK040990 Modification to Self-Drilling Radiographic MarkersWalter Lorenz Surgical, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K040990Modification to Self-Drilling Radiographic MarkersWalter Lorenz Surgical, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K014148, 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

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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
*	K010348	Tantalum Beads - Radiographic Marker Summary page 1 …metic Act for implantable radiographic markers. 4. PREDICATE DEVICE. The predicate device is the Tantalum Bead — Radiographic Marker cleared under Biomet 510(k) number K010348 on May 3, 2001. 5. DESCRIPTION OF THE DEVICE Self-Drilling Radiographic Markers are stainless steel bone screws used as radiogr…	Biomet, Inc.	2001	—

Also cleared against K010348: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040990	Modification to Self-Drilling Radiographic Markers	Walter Lorenz Surgical, Inc.	2004	0

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?

Its one ancestor has no recall.
Of its descendants, K040990 (Walter Lorenz Surgical, Inc., 2004) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K010348.

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014148: Self-Drilling Radiographic Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014148

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026