510(k) · Cleared
ClearedPalacos R+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 Sep 5, 2014 as substantially equivalent to K031673 (Heraeus Kulzer GmbH & Co. KG, 2004) after a 30-day review. Its family tree reaches back 2 generations to 1984. 4 later devices descend from it.
- Decided
- Sep 5, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P810020 (1984). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 1 generation backK031673 Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG · 2004 · Recalled
- This deviceK142157 Palacos R+G ProHeraeus Medical GmbH · 2014
- Descendant · cites it directly · 3 of its ownK202475 PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH · 2020
- Descendant · 2 generations on · 1 of its ownK210607 PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK211869 OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · 2022
- Descendant · 3 generations on · 0 of its ownK213812 PALACOS MV proHeraeus Medical GmbH · 2022 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH · 2020 · cites it directly3descendants
- K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH · 2021 · 2 generations on1descendant
- K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · 2022 · 2 generations on0descendants
- K213812PALACOS MV proHeraeus Medical GmbH · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −1 | K031673 | Refobacin -Palacos G | Heraeus Kulzer GmbH & Co. KG | 2004 | 1 |
| 0 (this device) | 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 | — |
| +2 | K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Heraeus Medical GmbH | 2021 | 6 |
| +2 | K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate… | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE | 2022 | — |
| +3 | K213812 | PALACOS MV pro | Heraeus Medical GmbH | 2022 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K031673 | Refobacin -Palacos GSummary page 4…name Polymethylmethacrylate (PMMA) bone cement Device code LOD, MBB, KIH, JDZ Identification of the marketed PALACOS® R+G, K031673 device to which equivalence is claimed Reference device SmartMix Cemvac Pre-filled with SmartSet GHV… | 2004 |
| † | K053445 | Smartmix Cemvac Pre-Filled with Smartset HV Bone Cement | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | 2020 | 3 |
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 30 years and passes through 3 companies; a new generation was cleared every 20.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K202475 (Heraeus Medical GmbH, 2020) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K031673.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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+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 as stated in the FDA summary.
https://510kreport.com/device/K142157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142157: Palacos R+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/K142157
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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