510(k) · Cleared
ClearedBonOs HV Genta, BonOs MV Genta, BonOs LV Genta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osartis GmbH · LOD Bone Cement
Cleared on Mar 19, 2021 as substantially equivalent to K143100 (Cossington, Ltd., 2015) and 1 other predicate after a 59-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Mar 19, 2021
- Review
- 59 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000943 (2001). 7 ancestors in all, the oldest P810020 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK000943 Cemex System Gun Application VersionExactech, Inc. · 2001
- 4 generations backK033596 Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc. · 2004
- 3 generations backK043403 Cemex System Genta Fast Bone CementExactech, Inc. · 2004
- 2 generations backK092773 Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009
- 1 generation backK143100 NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP…Cossington, Ltd. · 2015
- This deviceK210125 BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000943 | Cemex System Gun Application Version | Exactech, Inc. | 2001 | — |
| −4 | K033596 | Cemex Genta Bone Cement; Cemex Genta System Bone Cement | Exactech, Inc. | 2004 | — |
| −3 | K043403 | Cemex System Genta Fast Bone Cement | Exactech, Inc. | 2004 | — |
| −2 | K092773 | Cemex Genta, Genta System and Genta System Fast | Tecres S.P.A. | 2009 | — |
| −1 | K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV… | Cossington, Ltd. | 2015 | — |
| 0 (this device) | K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | Osartis GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2004 | 1 | 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 LOD? 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 LOD device
- #1 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 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 |
|---|---|---|---|
| * | K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaSummary page 5…ntibiotics Panel: Orthopedic 3. Predicate Device The predicate devices are as follows: - Rally™ HV AB Bone Cement (510(k) application K143100) - Palacos® R+G (510(k) application K031673) 4. Device Description BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta… | 2015 |
| * | K031673 | Refobacin -Palacos GSummary page 5…edic 3. Predicate Device The predicate devices are as follows: - Rally™ HV AB Bone Cement (510(k) application K143100) - Palacos® R+G (510(k) application K031673) 4. Device Description BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are PMMA, radiopaque bone cements, containing ge… | 2004 |
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 20 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K143100.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LOD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOD
277in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOD
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOD
355in 2025
MAUDE reports naming product code LOD, 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 | 2 | — | 0 | 78 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 3 | 103 | 0 | 170 |
| 2010 | 0 | — | 0 | 291 |
| 2011 | 0 | — | 0 | 428 |
| 2012 | 0 | — | 0 | 412 |
| 2013 | 2 | — | 0 | 501 |
| 2014 | 1 | — | 1 | 465 |
| 2015 | 4 | 138 | 0 | 529 |
| 2016 | 1 | — | 0 | 615 |
| 2017 | 3 | 96 | 4 | 817 |
| 2018 | 2 | — | 0 | 1,295 |
| 2019 | 4 | 90 | 0 | 2,307 |
| 2020 | 3 | 139 | 1 | 1,294 |
| 2021 | 4 | 95 | 0 | 782 |
| 2022 | 3 | 277 | 2 | 472 |
| 2023 | 2 | — | 0 | 475 |
| 2024 | 1 | — | 0 | 492 |
| 2025 | 1 | — | 0 | 355 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are intended for the fixation of prothesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
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/K210125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210125: BonOs HV Genta, BonOs MV Genta, BonOs LV Genta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210125
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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