510(k) · Cleared
Recalled · Class II · 2026PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Medical GmbH · LOD Bone Cement
Cleared on Jul 9, 2021 as substantially equivalent to K202475 (Heraeus Medical GmbH, 2020) after a 130-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Jul 9, 2021
- Review
- 130 days
- Class
- Class II
- Product code
- LOD
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 4 generations to P810020 (1984). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 3 generations backK031673 Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG · 2004 · Recalled
- 2 generations backK142157 Palacos R+G ProHeraeus Medical GmbH · 2014
- 1 generation backK202475 PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH · 2020
- This deviceK210607 PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH · 2021
- Descendant · cites it directly · 0 of its ownK213812 PALACOS MV proHeraeus Medical GmbH · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K213812PALACOS MV proHeraeus Medical GmbH · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −3 | K031673 | Refobacin -Palacos G | Heraeus Kulzer GmbH & Co. KG | 2004 | 1 |
| −2 | K142157 | Palacos R+G Pro | Heraeus Medical GmbH | 2014 | — |
| −1 | K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | Heraeus Medical GmbH | 2020 | — |
| 0 (this device) | K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Heraeus Medical GmbH | 2021 | — |
| +1 | K213812 | PALACOS MV pro | Heraeus Medical GmbH | 2022 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GSummary page 7…PALACOS® R+G pro, PALACOS® MV+G pro Subsequent Product Code(s): KIH, JDZ III. PREDICATE DEVICES PALACOS® R pro PALACOS® R pro (K202475, Predicate device) PALACOS® R (K202475, Reference device) PALACOS® R+G pro PALACOS® R+G pro (K202475, Predicate device) PALACOS… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213812 | PALACOS MV pro | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2026 | Class II | Z-3302-2026 | Under Investigation by firm | Potential for monomer liquid leakage. |
| Aug 20, 2026 | Class II | Z-3301-2026 | Under Investigation by firm | Potential for monomer liquid leakage. |
| Aug 20, 2026 | Class II | Z-3303-2026 | Under Investigation by firm | Potential for monomer liquid leakage. |
| Dec 9, 2025 | Class II | Z-1081-2026 | Under Investigation by firm | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence… |
| Dec 9, 2025 | Class II | Z-1082-2026 | Under Investigation by firm | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence… |
| Dec 9, 2025 | Class II | Z-1080-2026 | Under Investigation by firm | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K213812 (Heraeus Medical GmbH, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K202475.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
PALACOS® R pro is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
PALACOS® R+G pro is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
PALACOS® MV+G pro 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210607: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210607
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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