510(k) · Cleared

Cleared

Tantalum Bead Set, Model P003175

K090581510(k) TraditionalCleared Aug 21, 2009171-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

Halifax Biomedical, Inc. · NEU Marker, Radiographic, Implantable

Cleared on Aug 21, 2009 as substantially equivalent to K010348 (Biomet, Inc., 2001) after a 171-day review. Its family tree reaches back 1 generation to 2001.

Decided: Aug 21, 2009
Review: 171 days
Class: Class II
Product code: NEU
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010348 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK010348 Tantalum Beads - Radiographic MarkerBiomet, Inc. · 2001
This deviceK090581 Tantalum Bead Set, Model P003175Halifax Biomedical, Inc. · 2009

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)	K090581	Tantalum Bead Set, Model P003175	Halifax Biomedical, Inc.	2009	—

FIG. 1 — Lineage of K090581, 2001–2009Source: 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
*	K010348	Tantalum Beads - Radiographic Marker Summary page 1 …dicate Device: Substantial equivalence is claimed to the following device as related to intended use and design characteristics: Tantalum Beads, Biomnet, Inc. K010348 Description of the Device The Tantalum Bead Set consists of 1mnm spherical x-ray markers made of commercially pure, unalloyed t…	Biomet, Inc.	2001	—

Also cleared against K010348: 6 other devices →

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?

Its one ancestor has no recall.
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. 2009, this device’s year, is highlighted.

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?

Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090581 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090581: Tantalum Bead Set, Model P003175.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090581

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