510(k) · Cleared

Cleared

Alumina V40 Head

K003413510(k) SpecialCleared Nov 24, 200022-day reviewClass II21 CFR 888.3353

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

Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Nov 24, 2000 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.

Decided: Nov 24, 2000
Review: 22 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 0

20 later devices descend from it, 1 citing it directly.

This deviceK003413 Alumina V40 HeadHowmedica Osteonics Corp. · 2000
Descendant · cites it directly · 19 of its ownK023901 Alumina V40 Femoral HeadsHowmedica Osteonics Corp. · 2003
Descendant · 2 generations on · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
Descendant · 3 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
Descendant · 3 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
Descendant · 3 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2003high 4 (2022) · low 0 (2004)2026

Most influential descendants

Showing 5 of 20 · See all

K023901Alumina V40 Femoral HeadsHowmedica Osteonics Corp. · 2003 · cites it directly19descendants
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · 2 generations on17descendants
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 3 generations on8descendants
K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 3 generations on7descendants
K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003413	Alumina V40 Head	Howmedica Osteonics Corp.	2000	—
+1	K023901	Alumina V40 Femoral Heads	Howmedica Osteonics Corp.	2003	—
+2	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1
+3	K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads	Stryker Orthopaedics	2018	2
+3	K182468	Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II…	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	2019	—
+3	K220731	Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem	Stryker	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2007	1	0
2016	1	0
2018	1	0
2019	2	0
2020	1	0
2021	1	0
2022	4	0
2023	1	0
2024	2	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K003413, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LZO? 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 LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K023901	Alumina V40 Femoral Heads	Howmedica Osteonics Corp.	2003	19

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?

Of its descendants, K023901 (Howmedica Osteonics Corp., 2003) has gone furthest, with 19 descendants of its own.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

https://510kreport.com/device/K003413 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003413: Alumina V40 Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003413

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026