510(k) Report

510(k) · Cleared

Cleared

Palacos R Bone Cement with Gentamicin

K030086510(k) TraditionalCleared Dec 17, 2003342-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

Biomet, Inc. · LOD Bone Cement

Cleared on Dec 17, 2003 as substantially equivalent to P810020 (Smith & Nephew Richards, Inc., 1984) after a 342-day review. Its family tree reaches back 1 generation to 1984. 25 later devices descend from it.

Decided
Dec 17, 2003
Review
342 days
Class
Class II
Product code
LOD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to P810020 (1984). 25 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2004: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2019: 6 descendants cleared2012: 1 descendant cleared2020: 2 descendants cleared2018: 1 descendant cleared2024: 3 descendants cleared2025: 1 descendant cleared2026: 3 descendants cleared2022: 1 descendant cleared2023: 2 descendants clearedP810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalled19801990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 8 descendants6 generations forward: 7 descendants7 generations forward: 1 descendant P810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalled0+5
  1. Root · 1 generation backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
  2. This deviceK030086 Palacos R Bone Cement with GentamicinBiomet, Inc. · 2003
  3. Descendant · cites it directly · 23 of its ownK051532 Cobalt G HV Bone CementBiomet, Inc. · 2005
  4. Descendant · 2 generations on · 20 of its ownK062273 Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008
  5. Descendant · 3 generations on · 19 of its ownK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
  6. Descendant · 4 generations on · 16 of its ownK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
  7. Descendant · 5 generations on · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12008: 12009: 12011: 12012: 12018: 12019: 62020: 22022: 12023: 22024: 32025: 12026: 3
2004high 6 (2019) · low 0 (2006)2026

Most influential descendants

Showing 5 of 25 · See all
  • K051532Cobalt G HV Bone CementBiomet, Inc. · 2005 · cites it directly23descendants
  • K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008 · 2 generations on20descendants
  • K101356Spacer-G and Spacer-KTecres S.P.A. · 2011 · 3 generations on19descendants
  • K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012 · 4 generations on16descendants
  • K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P810020Palacos R Bone CementSmith & Nephew Richards, Inc.19841
0 (this device)K030086Palacos R Bone Cement with GentamicinBiomet, Inc.2003—
+1K051532Cobalt G HV Bone CementBiomet, Inc.2005—
+2K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A.2008—
+3K101356Spacer-G and Spacer-KTecres S.P.A.2011—
+4K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC2012—
+5K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200810
200910
201110
201210
201810
201960
202020
202210
202320
202430
202510
202630
FIG. 1 — Lineage of K030086, 1984–2026Source: 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
…e Device: Palacos® G Bone Cement (with Gentamicin) Legally marketed device to which the submitter claims substantial equivalence: Palacos® PMMA bone cement, FDA PMA No. P810020 (1984) - Subsequently reclassified into class II. Description Of Palacos® G (with Gentamicin) Palacos® G (with gentamicin) is a…
Smith & Nephew Richards, Inc.19841

Also cleared against P810020: 8 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K051532Cobalt G HV Bone CementBiomet, Inc.200523
K022688Versabond AB Bone CementSmith & Nephew, Inc.20040

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, K051532 (Biomet, Inc., 2005) has gone furthest, with 23 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®G with gentamicin is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

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
  • K030903OsteopalHeraeus Kulzer GmbH & Co. KG · 2003
  • K030902Palacos RHeraeus Kulzer GmbH & Co. KG · 2003

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K030086 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030086: Palacos R Bone Cement with Gentamicin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030086

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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