510(k) · Cleared

Cleared

Smartset HV Bone Cement

K023012510(k) TraditionalCleared Feb 13, 2003156-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

DePuy Orthopaedics, Inc. · LOD Bone Cement

Cleared on Feb 13, 2003 as substantially equivalent to P960001 (Depuy, Inc., 1997) and 1 other predicate after a 156-day review. Its family tree reaches back 1 generation to 1984. 12 later devices descend from it.

Decided: Feb 13, 2003
Review: 156 days
Class: Class II
Product code: LOD
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to P810020 (1984). 2 ancestors in all. 12 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
This deviceK023012 Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003
Descendant · cites it directly · 9 of its ownK033563 Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · Recalled
Descendant · 2 generations on · 8 of its ownK041656 Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV…DePuy Orthopaedics, Inc. · 2004
Descendant · 3 generations on · 4 of its ownK053002 Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005
Descendant · 4 generations on · 2 of its ownK173494 OrthoSteady G Bone CementG21, S.R.L. · 2018
Descendant · cites it directly · 1 of its ownK081155 Smartset MV Bone CementDePuy Orthopaedics, Inc. · 2008

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2004high 3 (2004) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all

K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · cites it directly9descendants
K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…DePuy Orthopaedics, Inc. · 2004 · 2 generations on8descendants
K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005 · 3 generations on4descendants
K173494OrthoSteady G Bone CementG21, S.R.L. · 2018 · 4 generations on2descendants
K081155Smartset MV Bone CementDePuy Orthopaedics, Inc. · 2008 · 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)	K023012	Smartset HV Bone Cement	DePuy Orthopaedics, Inc.	2003	—
+1	K033563	Smartset GHV Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2004	1
+2	K041656	Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance…	DePuy Orthopaedics, Inc.	2004	—
+3	K053002	Depuy CMW 1 Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2005	—
+4	K173494	OrthoSteady G Bone Cement	G21, S.R.L.	2018	—
+1	K081155	Smartset MV Bone Cement	DePuy Orthopaedics, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	1	0
2006	2	0
2008	2	0
2018	1	0
2020	2	0
2026	1	0

FIG. 1 — Lineage of K023012, 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	P960001	Depuy 1 Bone Cement Summary page 1 …PMMA Bone Cement: Class I1 per 2 1 CFR 888.3027 DEVICE CODE: LOD EQUIVALENT DEVICES: DePuy 1 Bone Cement - P960001/Supplement 3 Palacos R40 Bone Cement - P8 10020/Supplement 3 DEVICE DESCRIPTION AND INTEN…	Depuy, Inc.	1997	—
*	P810020	Palacos R Bone Cement Summary page 1 …LOD EQUIVALENT DEVICES: DePuy 1 Bone Cement - P960001/Supplement 3 Palacos R40 Bone Cement - P8 10020/Supplement 3 DEVICE DESCRIPTION AND INTENDED USE: SmartSet HV Bone Cement is a high viscosity bone cement which is equally suite…	Smith & Nephew Richards, Inc.	1984	1

Also cleared against P960001: 5 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K033563	Smartset GHV Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2004	9
K081155	Smartset MV Bone Cement	DePuy Orthopaedics, Inc.	2008	1
K053445	Smartmix Cemvac Pre-Filled with Smartset HV Bone Cement	DePuy Orthopaedics, Inc.	2006	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K033563 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 9 descendants of its own.
5 other devices also cite its predicate P960001.

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?

SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023012 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023012: Smartset HV Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023012

Report an extraction error

Are you the manufacturer?

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