PMA · Approved
Recalled · 2003Palacos R Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · LOD Bone Cement
Approved on Feb 2, 1984 through premarket approval, which rests on the device’s own clinical evidence after a 995-day review. 104 later devices descend from it. It has been recalled once.
- Decided
- Feb 2, 1984
- Review
- 995 days
- Class
- Class II
- Product code
- LOD
- Recalls
- 1
104 later devices descend from it, 9 citing it directly.
- This deviceP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984
- Descendant · cites it directly · 40 of its ownK030903 OsteopalHeraeus Kulzer GmbH & Co. KG · 2003
- Descendant · 2 generations on · 38 of its ownK050085 Osteopal VHeraeus Kulzer,GmbH · 2005
- Descendant · 3 generations on · 28 of its ownK150408 V-Steady, V-FastG21, S.R.L. · 2015
- Descendant · 4 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- Descendant · cites it directly · 25 of its ownK030086 Palacos R Bone Cement with GentamicinBiomet, Inc. · 2003
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 104 · See all- K030903OsteopalHeraeus Kulzer GmbH & Co. KG · 2003 · cites it directly40descendants
- K050085Osteopal VHeraeus Kulzer,GmbH · 2005 · 2 generations on38descendants
- K150408V-Steady, V-FastG21, S.R.L. · 2015 · 3 generations on28descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 4 generations on27descendants
- K030086Palacos R Bone Cement with GentamicinBiomet, Inc. · 2003 · cites it directly25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | — |
| +1 | K030903 | Osteopal | Heraeus Kulzer GmbH & Co. KG | 2003 | — |
| +2 | K050085 | Osteopal V | Heraeus Kulzer,GmbH | 2005 | — |
| +3 | K150408 | V-Steady, V-Fast | G21, S.R.L. | 2015 | — |
| +4 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| +1 | K030086 | Palacos R Bone Cement with Gentamicin | Biomet, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 8 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 14 | 0 |
| 2025 | 6 | 0 |
| 2026 | 10 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (104)
See all 1049 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 17, 2003 | Not classified | Z-0546-03 | Other | There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030903 (Heraeus Kulzer GmbH & Co. KG, 2003) has gone furthest, with 40 descendants of its own.
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 | — |
https://510kreport.com/device/P810020 · printed Nov 6, 2026
Cite this page
510(k) Report. “P810020: Palacos R Bone Cement.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P810020
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026