510(k) · Cleared
ClearedNP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cossington, Ltd. · LOD Bone Cement
Cleared on Mar 5, 2015 as substantially equivalent to K021715 (Exactech, Inc., 2002) after a 125-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Mar 5, 2015
- Review
- 125 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000943 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK000943 Cemex System Gun Application VersionExactech, Inc. · 2001
- 1 generation backK021715 Cemex RX, Cemex Isoplastic & Cemex XLExactech, Inc. · 2002
- This deviceK143134 NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV SystemCossington, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK211163 Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. · 2023
- Descendant · cites it directly · 0 of its ownK210120 BonOs HV, BonOs MV, BonOs LVOsartis GmbH · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000943 | Cemex System Gun Application Version | Exactech, Inc. | 2001 | — |
| −1 | K021715 | Cemex RX, Cemex Isoplastic & Cemex XL | Exactech, Inc. | 2002 | — |
| 0 (this device) | K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | Cossington, Ltd. | 2015 | — |
| +1 | K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | Tecres S.P.A. | 2023 | — |
| +1 | K210120 | BonOs HV, BonOs MV, BonOs LV | Osartis GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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? (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 | Decided |
|---|---|---|---|
| * | K021715 | Cemex RX, Cemex Isoplastic & Cemex XLSummary page 5…Orthopedic 3 PREDICATE DEVICE The predicate device is as follows: Tecres Cemex Isoplastic, which was cleared through 510(k) application K021715. 4 DEVICE DESCRIPTION The NP Cements and NP Cements System are PMMA, radiopaque bone cements, containing color additives to i… | 2002 |
What descends from it? (2)
2 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211163 (Tecres S.P.A., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K021715.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
NP Cements / NP Cements System are intended to be used for the fixation of artificial joint prostheses to the host bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143134 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143134: NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143134
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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