510(k) · Cleared
ClearedCemex RX, Cemex Isoplastic & Cemex XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LOD Bone Cement
Cleared on Jun 12, 2002 as substantially equivalent to K000943 (Exactech, Inc., 2001) after a 20-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Jun 12, 2002
- Review
- 20 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000943 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000943 Cemex System Gun Application VersionExactech, Inc. · 2001
- This deviceK021715 Cemex RX, Cemex Isoplastic & Cemex XLExactech, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK143134 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 · 2 generations on · 0 of its ownK210120 BonOs HV, BonOs MV, BonOs LVOsartis GmbH · 2021
Most influential descendants
Showing 3 of 3 · See all- K143134NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV SystemCossington, Ltd. · 2015 · cites it directly2descendants
- K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. · 2023 · cites it directly0descendants
- K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000943 | Cemex System Gun Application Version | Exactech, Inc. | 2001 | — |
| 0 (this device) | K021715 | Cemex RX, Cemex Isoplastic & Cemex XL | Exactech, Inc. | 2002 | — |
| +1 | 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 | — |
| +2 | K210120 | BonOs HV, BonOs MV, BonOs LV | Osartis GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K000943 | Cemex System Gun Application VersionSummary page 1…Bone Cement Legally Marketed Devices for Substantial Equivalence Comparison: Model Manufacturer Cemex System Tecres, S.p.A. (#K000943) CMW3 CMW Laboratories (Distributed by Dow Corning Wright) Simplex… | 2001 |
| * | — | CMW3 Named without a submission number | |
| * | — | Simplex P Named without a submission number | |
| * | — | Palacos R Named without a submission number | |
| * | — | Dough-Type Named without a submission number |
What descends from it? (3)
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?
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
CEMEX bone cement is indicated for the fixation of protheses to bone in orthopaedic musculoskeletal procedures for osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, tramatic arthritis, congenital deformities, avascular necrosis, post-traumatic degenerative problems of the joint, sickle cell anemia, osteoporosis, collagen disease and for the revision of previous arthroplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021715 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021715: Cemex RX, Cemex Isoplastic & Cemex XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021715
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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