510(k) · Cleared

Cleared

Bimetric Total Hip System

K921224510(k) TraditionalCleared Feb 16, 1994705-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

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

Cleared on Feb 16, 1994 after a 705-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.

Decided: Feb 16, 1994
Review: 705 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 0

21 later devices descend from it, 2 citing it directly.

This deviceK921224 Bimetric Total Hip SystemBiomet, Inc. · 1994
Descendant · cites it directly · 17 of its ownK020580 X-Series BI-Metric Hip Femoral ComponentsBiomet, Inc. · 2002
Descendant · 2 generations on · 13 of its ownK062775 European Style Taper,Press-Fit Hip StemOrtho Development Corp. · 2007 · Recalled
Descendant · 3 generations on · 5 of its ownK131022 Ovation 10/12 Hip StemOrtho Development Corp. · 2013
Descendant · 3 generations on · 4 of its ownK141001 Alpine Hip Stem; Alpine HA Hip StemOrtho Development · 2014
Descendant · 4 generations on · 3 of its ownK173880 Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2002high 4 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 21 · See all

K020580X-Series BI-Metric Hip Femoral ComponentsBiomet, Inc. · 2002 · cites it directly17descendants
K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp. · 2007 · 2 generations on13descendants
K131022Ovation 10/12 Hip StemOrtho Development Corp. · 2013 · 3 generations on5descendants
K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development · 2014 · 3 generations on4descendants
K173880Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K921224	Bimetric Total Hip System	Biomet, Inc.	1994	—
+1	K020580	X-Series BI-Metric Hip Femoral Components	Biomet, Inc.	2002	—
+2	K062775	European Style Taper,Press-Fit Hip Stem	Ortho Development Corp.	2007	4
+3	K131022	Ovation 10/12 Hip Stem	Ortho Development Corp.	2013	—
+3	K141001	Alpine Hip Stem; Alpine HA Hip Stem	Ortho Development	2014	—
+4	K173880	Corin TriFit CF Hip Stem	Corin U.S.A. Limited	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2005	1	0
2006	1	0
2007	1	0
2008	1	0
2013	1	0
2014	4	0
2015	1	0
2017	2	0
2018	1	0
2019	1	0
2021	1	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K921224, 1994–2026Source: 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? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K020580	X-Series BI-Metric Hip Femoral Components	Biomet, Inc.	2002	17
K050251	Balance Hip System	Biomet, Inc.	2005	2

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, K020580 (Biomet, Inc., 2002) has gone furthest, with 17 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/K921224 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921224: Bimetric Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921224

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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