510(k) Report

510(k) · Cleared

Cleared

Palacos R

K030902510(k) AbbreviatedCleared Sep 23, 2003183-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 Kulzer GmbH & Co. KG · LOD Bone Cement

Cleared on Sep 23, 2003 as substantially equivalent to P810020 (Smith & Nephew Richards, Inc., 1984) after a 183-day review. Its family tree reaches back 1 generation to 1984. 13 later devices descend from it.

Decided
Sep 23, 2003
Review
183 days
Class
Class II
Product code
LOD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to P810020 (1984). 13 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2020: 3 descendants cleared2006: 1 descendant cleared2021: 2 descendants cleared2013: 1 descendant cleared2007: 1 descendant cleared2022: 2 descendants clearedP810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalled19801990200020102020
Descendants, by generation 1 generation forward: 9 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant P810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalled0
  1. Root · 1 generation backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
  2. This deviceK030902 Palacos RHeraeus Kulzer GmbH & Co. KG · 2003
  3. Descendant · cites it directly · 4 of its ownK150119 PALACOS R proHeraeus Medical GmbH · 2015
  4. 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
  5. Descendant · 2 generations on · 1 of its ownK210607 PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH · 2021 · Recalled
  6. Descendant · cites it directly · 1 of its ownK053198 Simplex P Speedset Bone CementHowmedica Osteonics Corp. · 2006
  7. 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

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12013: 12015: 12017: 12019: 12020: 32021: 22022: 2
2006high 3 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 13 · See all
  • K150119PALACOS R proHeraeus Medical GmbH · 2015 · cites it directly4descendants
  • 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
  • K053198Simplex P Speedset Bone CementHowmedica Osteonics Corp. · 2006 · cites it directly1descendant
  • K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P810020Palacos R Bone CementSmith & Nephew Richards, Inc.19841
0 (this device)K030902Palacos RHeraeus Kulzer GmbH & Co. KG2003—
+1K150119PALACOS R proHeraeus Medical GmbH2015—
+1K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH2020—
+2K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH20216
+1K053198Simplex P Speedset Bone CementHowmedica Osteonics Corp.2006—
+2K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
201310
201510
201710
201910
202030
202120
202220
FIG. 1 — Lineage of K030902, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*P810020Palacos R Bone Cement
Summary page 1
…Bone Cement [dentification of the marketed device Palaces@' to PALACOS@R BONE CEMENT which eauivalence is claimed 1 PMA Number: P8 10020 Description of the device PalacoswR is an acrylic bone cement for use in…
Smith & Nephew Richards, Inc.19841

Also cleared against P810020: 8 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K150119PALACOS R proHeraeus Medical GmbH20154
K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH20203
K053198Simplex P Speedset Bone CementHowmedica Osteonics Corp.20061
K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH20210
K193061G3 40 Radiopaque Bone CementG21, S.R.L.20200
K193059G1 40 Radiopaque Bone CementG21, S.R.L.20200
K192394Hi-Fatigue Bone CementOsartis GmbH20190
K172408Biomet Bone Cement RBiomet, Inc.20170
K123225Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60Aap Biomaterials GmbH & Co. KG20130

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?

  • Its one ancestor has a recall.
  • Of its descendants, K150119 (Heraeus Medical GmbH, 2015) has gone furthest, with 4 descendants of its own.
  • 8 other devices also cite its predicate P810020.

How does its category compare?

All LOD devices

LOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Indications for use as stated in the FDA summary.

Also cleared against P810020

8 other devices cite the same predicate.

  • K051496Cobalt Bone CementBiomet, Inc. · 20054 recalls
  • K050855Palamed GHeraeus Kulzer,GmbH · 2005
  • K031673Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG · 20041 recall
  • K022688Versabond AB Bone CementSmith & Nephew, Inc. · 20041 recall
  • K030086Palacos R Bone Cement with GentamicinBiomet, Inc. · 2003
  • K030903OsteopalHeraeus Kulzer GmbH & Co. KG · 2003

More from Heraeus Kulzer GmbH & Co. KG

4 FDA decisions under this applicant name. See the company

  • K031673Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG · 20041 recall
  • K030903OsteopalHeraeus Kulzer GmbH & Co. KG · 2003
  • K022251PalabondHeraeus Kulzer GmbH & Co. KG · 2003

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/K030902 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030902: Palacos R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030902

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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