510(k) · Cleared

Recalled · Class II · 2013

Refobacin -Palacos G

K031673510(k) TraditionalCleared May 25, 2004361-day reviewClass II21 CFR 888.3027Recalls 1

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 May 25, 2004 as substantially equivalent to P810020 (Smith & Nephew Richards, Inc., 1984) after a 361-day review. Its family tree reaches back 1 generation to 1984. 15 later devices descend from it. It has been recalled once.

Decided: May 25, 2004
Review: 361 days
Class: Class II
Product code: LOD
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to P810020 (1984). 15 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
This deviceK031673 Refobacin -Palacos GHeraeus Kulzer GmbH & Co. KG · 2004
Descendant · cites it directly · 4 of its ownK142157 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 · cites it directly · 2 of its ownK173494 OrthoSteady G Bone CementG21, S.R.L. · 2018
Descendant · 2 generations on · 1 of its ownK210607 PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH · 2021 · Recalled
Descendant · cites it directly · 1 of its ownK171540 Refobacin Bone Cement RBiomet, Inc. · 2017

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2013high 3 (2020) · low 0 (2016)2026

Most influential descendants

Showing 5 of 15 · See all

K142157Palacos R+G ProHeraeus Medical GmbH · 2014 · cites it directly4descendants
K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH · 2020 · cites it directly3descendants
K173494OrthoSteady G Bone CementG21, S.R.L. · 2018 · cites it directly2descendants
K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH · 2021 · 2 generations on1descendant
K171540Refobacin Bone Cement RBiomet, Inc. · 2017 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P810020	Palacos R Bone Cement	Smith & Nephew Richards, Inc.	1984	1
0 (this device)	K031673	Refobacin -Palacos G	Heraeus Kulzer GmbH & Co. KG	2004	—
+1	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	—
+1	K173494	OrthoSteady G Bone Cement	G21, S.R.L.	2018	—
+2	K210607	PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro	Heraeus Medical GmbH	2021	6
+1	K171540	Refobacin Bone Cement R	Biomet, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0
2015	1	0
2017	1	0
2018	1	0
2019	2	0
2020	3	0
2021	2	0
2022	2	0
2026	1	0

FIG. 1 — Lineage of K031673, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	P810020	Palacos R Bone Cement Summary page 1 …ent Identification of the marketed device to which PALACOS ® R BONE CEMENT equivalence is claimed PMA Number: P810020 Description of the device Palacos ®G is an acrylic bone cement for use in…	Smith & Nephew Richards, Inc.	1984	1

Also cleared against P810020: 8 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K142157	Palacos R+G Pro	Heraeus Medical GmbH	2014	4
K202475	PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G	Heraeus Medical GmbH	2020	3
K173494	OrthoSteady G Bone Cement	G21, S.R.L.	2018	2
K171540	Refobacin Bone Cement R	Biomet, Inc.	2017	1
K210125	BonOs HV Genta, BonOs MV Genta, BonOs LV Genta	Osartis GmbH	2021	0
K192379	Hi-Fatigue G Bone Cement	Osartis GmbH	2019	0
K190766	PALACOS fast R+G	Heraeus Medical GmbH	2019	0
K150850	Refobacin Bone Cement R	Biomet, Inc.	2015	0
K123081	Bonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40…	Aap Biomaterials GmbH & Co. KG	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 4, 2013	Class II	Z-0730-2014	Other	The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K142157 (Heraeus Medical GmbH, 2014) 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

2007high 4 (2015) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOD

277in 2022

2007high 277 (2022) · low 90 (2019)2026

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

Recalls per year · LOD

2in 2022

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

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

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 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 as stated in the FDA summary.

https://510kreport.com/device/K031673 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031673: Refobacin -Palacos G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031673

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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