510(k) · Cleared
ClearedPalacos LV+G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer,GmbH · LOD Bone Cement
Cleared on Jul 7, 2005 as substantially equivalent to K030903 (Heraeus Kulzer GmbH & Co. KG, 2003) after a 94-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Jul 7, 2005
- Review
- 94 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P810020 (1984). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K030903 | OsteopalSummary page 1…A Bone Cement Classification name Bone Cement, 888.3027 Identification of the m~arketed device to which OSTEOPAL K030903 claimedPMA is e nivalence P810020 1998 Description of the… | 2003 |
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 21 years and passes through 3 companies; a new generation was cleared every 19.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K030903.
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?
PALACOS® LV + G is indicated for use 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/K050854 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050854: Palacos LV+G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050854
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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