510(k) · Cleared

Cleared

Solution Hip

K941942510(k) TraditionalCleared Jul 12, 199482-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

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

Cleared on Jul 12, 1994 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 212 later devices descend from it.

Decided: Jul 12, 1994
Review: 82 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 0

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

This deviceK941942 Solution HipDepuy, Inc. · 1994
Descendant · cites it directly · 209 of its ownK982367 Reach Hip ComponentBiomet, Inc. · 1998
Descendant · 2 generations on · 208 of its ownK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
Descendant · 3 generations on · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
Descendant · 3 generations on · 138 of its ownK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
Descendant · 4 generations on · 137 of its ownK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled

Showing 5 of 212 descendants. See all descendants

Descendants cleared per year

1997high 21 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 212 · See all

K982367Reach Hip ComponentBiomet, Inc. · 1998 · cites it directly209descendants
K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Biomet, Inc. · 2003 · 2 generations on208descendants
K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · 3 generations on160descendants
K050124Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · 3 generations on138descendants
K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · 4 generations on137descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K941942	Solution Hip	Depuy, Inc.	1994	—
+1	K982367	Reach Hip Component	Biomet, Inc.	1998	—
+2	K030055	Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric…	Biomet, Inc.	2003	3
+3	K043537	Taperloc 12/14 Taper Femoral Components	Biomet, Inc.	2005	—
+3	K050124	Porous Coated Acetabular Components	Biomet, Inc.	2005	1
+4	K070369	Regenerx Ringloc + Modular Acetabular Shells	Biomet, Inc.	2007	19

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2003	1	0
2005	5	0
2006	2	0
2007	3	0
2008	2	0
2009	1	0
2010	2	0
2011	4	0
2012	15	0
2013	10	0
2014	16	0
2015	11	0
2016	9	0
2017	12	0
2018	7	0
2019	21	0
2020	8	0
2021	8	0
2022	12	0
2023	14	0
2024	13	0
2025	16	0
2026	17	0

FIG. 1 — Lineage of K941942, 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? (212)

See all 212

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

Number	Device	Applicant	Decided	Descendants
K982367	Reach Hip Component	Biomet, Inc.	1998	209
K971824	Reach Femoral Hip Component	Biomet, Inc.	1997	1
K984154	Apf Porous Coated Line Extension	Biomet, Inc.	1999	0

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, K982367 (Biomet, Inc., 1998) has gone furthest, with 209 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/K941942 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941942: Solution Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941942

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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