510(k) · Cleared

Cleared

Modification to Versabond Bone Cement

K033509510(k) SpecialCleared Nov 28, 200322-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

Cleared on Nov 28, 2003 as substantially equivalent to K001160 (Smith & Nephew, Inc., 2000) after a 22-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Nov 28, 2003
Review: 22 days
Class: Class II
Product code: LOD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001160 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001160 Versabond Bone CementSmith & Nephew, Inc. · 2000
This deviceK033509 Modification to Versabond Bone CementSmith & Nephew, Inc. · 2003
Descendant · cites it directly · 0 of its ownK022688 Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K022688Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001160	Versabond Bone Cement	Smith & Nephew, Inc.	2000	—
0 (this device)	K033509	Modification to Versabond Bone Cement	Smith & Nephew, Inc.	2003	—
+1	K022688	Versabond AB Bone Cement	Smith & Nephew, Inc.	2004	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K033509, 2000–2004Source: 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? (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
*	K001160	Versabond Bone Cement Summary page 1 …valence Information: The indications for use, chemical formulation, and design features of VersaBond Bone Cement are substantially equivalent to the device cleared under K001160. DEPARTMENT OF HEALTH &HUMAN SERVICES Public Health Service ‘…	Smith & Nephew, Inc.	2000	—

Also cleared against K001160: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022688	Versabond AB Bone Cement	Smith & Nephew, Inc.	2004	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?

Its one ancestor has no recall.
Of its descendants, K022688 (Smith & Nephew, Inc., 2004) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K001160.

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?

VersaBond" Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, osteoporosis, secondary severe joint destruction following trauma or other conditions, and revision of previous arthroplasty procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033509: Modification to Versabond 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/K033509

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