510(k) · Cleared
ClearedTantalum Beads - Radiographic Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · NEU Marker, Radiographic, Implantable
Cleared on May 3, 2001 after an 87-day review. The FDA summary names its predicate without a number. 63 later devices descend from it.
- Decided
- May 3, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 7 citing it directly.
- This deviceK010348 Tantalum Beads - Radiographic MarkerBiomet, Inc. · 2001
- Descendant · cites it directly · 38 of its ownK063422 BioaggregateInnovative Bioceramix, Inc. · 2006
- Descendant · 2 generations on · 37 of its ownK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- Descendant · cites it directly · 17 of its ownK011856 Radiographic MarkersEncore Orthopedics, Inc. · 2001
- Descendant · cites it directly · 16 of its ownK061066 Synergy Hip SystemSmith & Nephew, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK111546 U2 Hip SystemUnited Orthopedic Corp. · 2011 · Recalled
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K063422BioaggregateInnovative Bioceramix, Inc. · 2006 · cites it directly38descendants
- K080917Iroot SPInnovative Bioceramix, Inc. · 2008 · 2 generations on37descendants
- K011856Radiographic MarkersEncore Orthopedics, Inc. · 2001 · cites it directly17descendants
- K061066Synergy Hip SystemSmith & Nephew, Inc. · 2006 · cites it directly16descendants
- K111546U2 Hip SystemUnited Orthopedic Corp. · 2011 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010348 | Tantalum Beads - Radiographic Marker | Biomet, Inc. | 2001 | — |
| +1 | K063422 | Bioaggregate | Innovative Bioceramix, Inc. | 2006 | — |
| +2 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| +1 | K011856 | Radiographic Markers | Encore Orthopedics, Inc. | 2001 | — |
| +1 | K061066 | Synergy Hip System | Smith & Nephew, Inc. | 2006 | — |
| +2 | K111546 | U2 Hip System | United Orthopedic Corp. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | — | UltraClip Tissue Marker Named without a submission number | |
| * | — | Micromark Clip Named without a submission number |
What descends from it? (63)
See all 637 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K063422 (Innovative Bioceramix, Inc., 2006) has gone furthest, with 38 descendants of its own.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 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 beads are used as radiopaque 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. Implant surgery associated with the use of radiographic markers may include total joint replacement, soft tissue repair, and bone fixation.
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/K010348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010348: Tantalum Beads - 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/K010348
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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