510(k) · Cleared
ClearedRefobacin Bone Cement R (110034355)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet France · LOD Bone Cement
Cleared on Apr 15, 2026 as substantially equivalent to K171540 (Biomet, Inc., 2017) after a 117-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Apr 15, 2026
- Review
- 117 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P810020 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 2 generations backK031673 Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG · 2004 · Recalled
- 1 generation backK171540 Refobacin Bone Cement RBiomet, Inc. · 2017
- This deviceK254107 Refobacin Bone Cement R (110034355)Biomet France · 2026
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 K231556 SPECTRUM® GV Bone Cementscore 11.0 · 6 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 |
|---|---|---|---|
| * | K171540 | Refobacin Bone Cement RSummary page 5….3027 Product Code(s) LOD, VBB I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K171540 Refobacin Bone Cement R MBB Device Description Summary 21 CFR 807.92(a)(4) Refobacin Bone Cement R (RBCR) is a fast-setting acry… | 2017 |
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 42 years and passes through 4 companies; a new generation was cleared every 13.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Refobacin Bone Cement R is indicated to be used for stable anchoring of suitable joint prostheses to the bone, in hip and knee revision arthroplasty operations when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection, also in case an infection with gentamicin-sensitive strains is a potential risk.
Refobacin Bone Cement R is indicated to be used in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254107: Refobacin Bone Cement R (110034355).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254107
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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