510(k) Report

510(k) · Cleared

Cleared

PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G

K202475510(k) TraditionalCleared Nov 23, 202087-day reviewClass II21 CFR 888.3027

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Heraeus Medical GmbH · LOD Bone Cement

Cleared on Nov 23, 2020 as substantially equivalent to K030902 (Heraeus Kulzer GmbH & Co. KG, 2003) and 4 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1984. 3 later devices descend from it.

Decided
Nov 23, 2020
Review
87 days
Class
Class II
Product code
LOD
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to P810020 (1984). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2022: 2 descendants cleared2021: 1 descendant clearedP810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalledK031673 · Refobacin -Palacos G · Heraeus Kulzer GmbH & Co. KG · 2004 · recalledK142157 · Palacos R+G Pro · Heraeus Medical GmbH · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K142157 · Palacos R+G Pro · Heraeus Medical GmbH · 2014K031673 · Refobacin -Palacos G · Heraeus Kulzer GmbH & Co. KG · 2004 · recalledP810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalled0
  1. Root · 3 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
  2. 2 generations backK031673 Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG · 2004 · Recalled
  3. 1 generation backK142157 Palacos R+G ProHeraeus Medical GmbH · 2014
  4. This deviceK202475 PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH · 2020
  5. Descendant · cites it directly · 1 of its ownK210607 PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH · 2021 · Recalled
  6. Descendant · cites it directly · 0 of its ownK211869 OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · 2022
  7. Descendant · 2 generations on · 0 of its ownK213812 PALACOS MV proHeraeus Medical GmbH · 2022 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH · 2021 · cites it directly1descendant
  • K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · 2022 · cites it directly0descendants
  • K213812PALACOS MV proHeraeus Medical GmbH · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3P810020Palacos R Bone CementSmith & Nephew Richards, Inc.19841
−2K031673Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG20041
−1K142157Palacos R+G ProHeraeus Medical GmbH2014—
0 (this device)K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH2020—
+1K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH20216
+1K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE2022—
+2K213812PALACOS MV proHeraeus Medical GmbH20222

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202220
FIG. 1 — Lineage of K202475, 1984–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K030902Palacos R
Summary page 9
…LACOS® R+G pro, PALACOS® R+G, PALACOS® MV+G Subsequent Product Code(s): KIH, JDZ III. PREDICATE DEVICES PALACOS® R (K030902) PALACOS® R pro (K150119) PALACOS® G (K031673) PALACOS® R+G pro (K142157) PALAMED G (K050855) No reference devices were used in…
Heraeus Kulzer GmbH & Co. KG2003—
*K150119PALACOS R pro
Summary page 9
…R+G, PALACOS® MV+G Subsequent Product Code(s): KIH, JDZ III. PREDICATE DEVICES PALACOS® R (K030902) PALACOS® R pro (K150119) PALACOS® G (K031673) PALACOS® R+G pro (K142157) PALAMED G (K050855) No reference devices were used in this submission. IV.…
Heraeus Medical GmbH2015—
*K031673Refobacin -Palacos G
Summary page 9
…MV+G Subsequent Product Code(s): KIH, JDZ III. PREDICATE DEVICES PALACOS® R (K030902) PALACOS® R pro (K150119) PALACOS® G (K031673) PALACOS® R+G pro (K142157) PALAMED G (K050855) No reference devices were used in this submission. IV. DEVICE DESCRIPT…
Heraeus Kulzer GmbH & Co. KG20041
*K142157Palacos R+G Pro
Summary page 9
…MV+G Subsequent Product Code(s): KIH, JDZ III. PREDICATE DEVICES PALACOS® R (K030902) PALACOS® R pro (K150119) PALACOS® G (K031673) PALACOS® R+G pro (K142157) PALAMED G (K050855) No reference devices were used in this submission. IV. DEVICE DESCRIPTION A bundled Traditional 5…
Heraeus Medical GmbH2014—
*K050855Palamed G
Summary page 9
…roduct Code(s): KIH, JDZ III. PREDICATE DEVICES PALACOS® R (K030902) PALACOS® R pro (K150119) PALACOS® G (K031673) PALACOS® R+G pro (K142157) PALAMED G (K050855) No reference devices were used in this submission. IV. DEVICE DESCRIPTION A bundled Traditional 510(k) submission is…
Heraeus Kulzer,GmbH2005—

Also cleared against K030902: 8 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH20211
K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE20220

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 36 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K210607 (Heraeus Medical GmbH, 2021) has gone furthest, with 1 descendant of its own.
  • 8 other devices also cite its predicate K030902.

How does its category compare?

All LOD devices

LOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · LOD

1in 2025

2007: 22008: 12009: 32013: 22014: 12015: 42016: 12017: 32018: 22019: 42020: 32021: 42022: 32023: 22024: 12025: 12026 (partial year): 1
2007high 4 (2015) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOD

277in 2022

2009: 103 days median2015: 138 days median2017: 96 days median2019: 90 days median2020: 139 days median2021: 95 days median2022: 277 days median
2007high 277 (2022) · low 90 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LOD

2in 2022

2014: 12017: 42020: 12022: 22026 (partial year): 2
2007high 4 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LOD

355in 2025

2007: 782008: 1342009: 1702010: 2912011: 4282012: 4122013: 5012014: 4652015: 5292016: 6152017: 8172018: 1,2952019: 2,3072020: 1,2942021: 7822022: 4722023: 4752024: 4922025: 355
2007high 2,307 (2019) · low 78 (2007)2025

MAUDE reports naming product code LOD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—078
20081—0134
200931030170
20100—0291
20110—0428
20120—0412
20132—0501
20141—1465
201541380529
20161—0615
20173964817
20182—01,295
201949002,307
2020313911,294
20214950782
202232772472
20232—0475
20241—0492
20251—0355
20261—2—

What is it indicated for?

PALACOS® R 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 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 is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after…

Read the full statement (133 words)

PALACOS® R 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 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 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® 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 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.

Also cleared against K030902

8 other devices cite the same predicate.

  • K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH · 2021
  • K193059G1 40 Radiopaque Bone CementG21, S.R.L. · 2020
  • K193061G3 40 Radiopaque Bone CementG21, S.R.L. · 2020
  • K192394Hi-Fatigue Bone CementOsartis GmbH · 2019
  • K172408Biomet Bone Cement RBiomet, Inc. · 2017
  • K150119PALACOS R proHeraeus Medical GmbH · 2015

More from Heraeus Medical GmbH

13 FDA decisions under this applicant name. See the company

  • K241674Osteopal® VHeraeus Medical GmbH · 2024
  • K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH · 2024
  • K222570COPAL knee mouldsHeraeus Medical GmbH · 2023
  • K220492COPAL exchange G hip spacerHeraeus Medical GmbH · 2022
  • K213812PALACOS MV proHeraeus Medical GmbH · 20222 recalls

Recent decisions in LOD

The LOD category page

  • K254107Refobacin Bone Cement R (110034355)Biomet France · 2026
  • K250760SPECTRUM GV Bone CementOsteoremedies, LLC · 2025
  • K241674Osteopal® VHeraeus Medical GmbH · 2024
  • K231556SPECTRUM® GV Bone CementOsteoremedies, LLC · 2023
  • K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. · 2023

https://510kreport.com/device/K202475 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202475: PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202475

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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