510(k) · Cleared
ClearedBone Cement Genta, Bone Cement HV, Bone Cement LV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tecres S.P.A. · LOD Bone Cement
Cleared on Jan 9, 2023 as substantially equivalent to K143100 (Cossington, Ltd., 2015) and 2 other predicates after a 630-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jan 9, 2023
- Review
- 630 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K000943 (2001). 7 ancestors in all. 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 deviceK211163 Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. · 2023
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) | K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | Tecres S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2015 | 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? (3)
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 6…PREDICATE DEVICES The predicate devices are as follows: Bone Cement Genta: Tecres S.p.A. NP Cement Genta HV, which was cleared originally through 510(k) application K143100. Bone Cement: For purposes of the substantial equivalence comparison, the following primary predicate device was selected:… | 2015 |
| * | K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV SystemSummary page 6…l equivalence comparison, the following primary predicate device was selected: • Tecres S.p.A. NP Cement HV, which was cleared through 510(k) application K143134. A second predicate bone cement identified below was utilized as for a comparison for the indication for use statement: •… | 2015 |
| * | K021715 | Cemex RX, Cemex Isoplastic & Cemex XLSummary page 6…identified below was utilized as for a comparison for the indication for use statement: • Tecres S.p.A. Cemex Bone Cement, which was through 510(k) application K021715. 4 DEVICE DESCRIPTION Bone Cement Genta The Bone Cement Genta are PMMA, radiopaque bone cements, containing gentamicin des… | 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 22 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 7 ancestors has a recall.
- 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. 2023, 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?
Bone Cement LV and HV are indicated for the fixation of joint prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, sickle cell anemia, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.
Bone Cement Genta are intended for the fixation of prosthesis 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 as stated in the FDA summary.
https://510kreport.com/device/K211163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211163: Bone Cement Genta, Bone Cement HV, Bone Cement LV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211163
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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