510(k) · Cleared

Recalled · Class III · 2022

Surgical Simplex P with Tobramycin

K014199510(k) TraditionalCleared May 6, 2003501-day reviewClass II21 CFR 888.3027Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Howmedica Osteonics Corp. · LOD Bone Cement

Cleared on May 6, 2003 after a 501-day review. The FDA summary names its predicate without a number. 21 later devices descend from it. It has been recalled 2 times.

Decided: May 6, 2003
Review: 501 days
Class: Class II
Product code: LOD
Recalls: 2
Predicates: 0

21 later devices descend from it, 4 citing it directly.

This deviceK014199 Surgical Simplex P with TobramycinHowmedica Osteonics Corp. · 2003
Descendant · cites it directly · 16 of its ownK033382 Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004
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 · 2 generations on · 4 of its ownK053002 Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005
Descendant · 3 generations on · 2 of its ownK173494 OrthoSteady G Bone CementG21, S.R.L. · 2018

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2004high 4 (2004) · low 0 (2010)2026

Most influential descendants

Showing 5 of 21 · See all

K033382Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · cites it directly16descendants
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 · 2 generations on4descendants
K173494OrthoSteady G Bone CementG21, S.R.L. · 2018 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K014199	Surgical Simplex P with Tobramycin	Howmedica Osteonics Corp.	2003	—
+1	K033382	Smartset GMV Endurance Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2004	—
+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	—
+2	K053002	Depuy CMW 1 Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2005	—
+3	K173494	OrthoSteady G Bone Cement	G21, S.R.L.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	4	0
2005	2	0
2006	2	0
2007	4	0
2008	1	0
2009	1	0
2011	1	0
2018	1	0
2019	1	0
2020	3	0
2022	1	0

FIG. 1 — Lineage of K014199, 2003–2022Source: 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? (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
*	—	Surgical Simplex® P Radiopaque Bone Cement (Howmedica Osteonics N-17-004) Named without a submission number			—
*	—	Surgical Simplex® P Bone Cement Named without a submission number			—

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K033382	Smartset GMV Endurance Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2004	16
K033563	Smartset GHV Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2004	9
K092150	Cobalt MV with Gentamicin (Aka Cobalt G-MV) Bone Cement	Biomet, Inc.	2009	1
K063857	Simplex P Speedset with Tobramycin Bone Cement	Howmedica Osteonics Corp.	2007	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 7, 2022	Class III	Z-0737-2023	Under Investigation by firm	Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
Nov 7, 2006	Not classified	Z-0467-2007	Other	The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K033382 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 16 descendants of its own.

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?

SimplexTMP with Tobramycin is indicated for the fixation of prostheses to living bone

for use in the second stage of a two-stage revision far total joint arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K014199 · printed Nov 3, 2026

Cite this page

510(k) Report. “K014199: Surgical Simplex P with Tobramycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014199

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026