510(k) · Cleared

Cleared

Osteonics Alumina C-Taper Head

K003391510(k) SpecialCleared Nov 28, 200028-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 28, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 174 later devices descend from it.

Decided: Nov 28, 2000
Review: 28 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 0

174 later devices descend from it, 3 citing it directly.

This deviceK003391 Osteonics Alumina C-Taper HeadHowmedica Osteonics Corp. · 2000
Descendant · cites it directly · 162 of its ownK022958 Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · Recalled
Descendant · 2 generations on · 149 of its ownK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
Descendant · 3 generations on · 140 of its ownK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
Descendant · 4 generations on · 110 of its ownK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
Descendant · 4 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011

Showing 5 of 174 descendants. See all descendants

Descendants cleared per year

2002high 17 (2022) · low 0 (2003)2026

Most influential descendants

Showing 5 of 174 · See all

K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · cites it directly162descendants
K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009 · 2 generations on149descendants
K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010 · 3 generations on140descendants
K103120Corin Biolox Delta Femoral HeadsCorin USA · 2011 · 4 generations on110descendants
K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 4 generations on109descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003391	Osteonics Alumina C-Taper Head	Howmedica Osteonics Corp.	2000	—
+1	K022958	Total Hip Femoral Heads and Liners	Smith & Nephew, Inc.	2002	1
+2	K083762	Biolox Delta Ceramic Femoral Heads	Smith & Nephew, Inc.	2009	—
+3	K100412	Biolox Delta Ceramic Femoral Heads	Smith & Nephew, Inc.	2010	—
+4	K103120	Corin Biolox Delta Femoral Heads	Corin USA	2011	—
+4	K110087	Corin Trinity Acetbular System with Hxlpe Liners	Corin USA	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2008	1	0
2009	1	0
2010	2	0
2011	8	0
2012	6	0
2013	15	0
2014	4	0
2015	6	0
2016	11	0
2017	9	0
2018	11	0
2019	14	0
2020	11	0
2021	8	0
2022	17	0
2023	13	0
2024	11	0
2025	14	0
2026	10	0

FIG. 1 — Lineage of K003391, 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? (174)

See all 174

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

Number	Device	Applicant	Decided	Descendants
K022958	Total Hip Femoral Heads and Liners	Smith & Nephew, Inc.	2002	162
K041940	Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads	Howmedica Osteonics Corp.	2005	18
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17

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, K022958 (Smith & Nephew, Inc., 2002) has gone furthest, with 162 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/K003391 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003391: Osteonics Alumina C-Taper Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003391

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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