510(k) · Cleared

Cleared

Exactech Ceramic Femoral Head Component

K914574510(k) TraditionalCleared Jan 13, 199290-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

Exactech, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jan 13, 1992 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 26 later devices descend from it.

Decided: Jan 13, 1992
Review: 90 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 0

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

This deviceK914574 Exactech Ceramic Femoral Head ComponentExactech, Inc. · 1992
Descendant · cites it directly · 25 of its ownK032964 Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series…Exactech, Inc. · 2003 · Recalled
Descendant · 2 generations on · 16 of its ownK073337 Mectacer Biolox Forte-Femoral HeadsMedacta International S.A. · 2008
Descendant · 3 generations on · 14 of its ownK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
Descendant · 3 generations on · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
Descendant · 4 generations on · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2003high 3 (2005) · low 0 (2004)2026

Most influential descendants

Showing 5 of 26 · See all

K032964Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck SegmentsExactech, Inc. · 2003 · cites it directly25descendants
K073337Mectacer Biolox Forte-Femoral HeadsMedacta International S.A. · 2008 · 2 generations on16descendants
K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011 · 3 generations on14descendants
K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · 3 generations on8descendants
K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K914574	Exactech Ceramic Femoral Head Component	Exactech, Inc.	1992	—
+1	K032964	Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck…	Exactech, Inc.	2003	1
+2	K073337	Mectacer Biolox Forte-Femoral Heads	Medacta International S.A.	2008	—
+3	K112115	Mectacer Biolox (R) Delta Femoral Heads	Medacta International	2011	—
+3	K121665	Bencox Foret & Bencox Delta	Corentec Co., Ltd.	2012	—
+4	K150007	Modified Bencox Hip System	Corentec Co., Ltd.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	3	0
2006	1	0
2008	1	0
2010	1	0
2011	1	0
2012	1	0
2013	3	0
2015	1	0
2016	2	0
2017	1	0
2018	1	0
2019	2	0
2021	1	0
2022	2	0
2023	1	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K914574, 1992–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K032964	Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments	Exactech, Inc.	2003	25

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, K032964 (Exactech, Inc., 2003) has gone furthest, with 25 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/K914574 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914574: Exactech Ceramic Femoral Head Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914574

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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