510(k) · Cleared

Recalled · 2011

Modular Dual Mobility Liner, X3 Acetabular Insert

K103233510(k) TraditionalCleared Feb 3, 201193-day reviewClass II21 CFR 888.3353Recalls 1

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 Feb 3, 2011 as substantially equivalent to K072020 (Howmedica Osteonics Corp., 2007) and 2 other predicates after a 93-day review. Its family tree reaches back 1 generation to 2001. 52 later devices descend from it. It has been recalled once.

Decided: Feb 3, 2011
Review: 93 days
Class: Class II
Product code: LZO
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K010170 (2001). 3 ancestors in all. 52 later devices descend from it, 11 citing it directly.

By dateBy generation

Root · 1 generation backK010170 Trident Porous Titanium Acetabular ComponentHowmedica Osteonics Corp. · 2001
This deviceK103233 Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp. · 2011
Descendant · cites it directly · 21 of its ownK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
Descendant · cites it directly · 10 of its ownK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
Descendant · cites it directly · 10 of its ownK112556 Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 InsertsHowmedica Osteonics Corp. · 2011 · Recalled
Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2011high 9 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 52 · See all

K150522G7 Dual Mobility SystemBiomet, Inc. · 2015 · cites it directly21descendants
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · cites it directly10descendants
K112556Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 InsertsHowmedica Osteonics Corp. · 2011 · cites it directly10descendants
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010170	Trident Porous Titanium Acetabular Component	Howmedica Osteonics Corp.	2001	—
0 (this device)	K103233	Modular Dual Mobility Liner, X3 Acetabular Insert	Howmedica Osteonics Corp.	2011	—
+1	K150522	G7 Dual Mobility System	Biomet, Inc.	2015	1
+1	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1
+1	K170359	Trinity™ Dual Mobility System	Corin U.S.A. Limited	2017	1
+1	K112556	Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts	Howmedica Osteonics Corp.	2011	1
+2	K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads	Stryker Orthopaedics	2018	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0
2015	2	0
2016	2	0
2017	1	0
2018	2	0
2019	6	0
2020	3	0
2021	5	0
2022	6	0
2023	3	0
2024	7	0
2025	9	0
2026	4	0

FIG. 1 — Lineage of K103233, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K072020	Restoration Adm System Summary page 2 …valence: Testing has been performed to demonstrate equivalence of the subject device compared to its predicate device. Predicate devices include Restoration® ADM System (K072020), Restoration® X3® Acetabular Insert (K093644), and Trident® Porous Titanium Acetabular Component (KO010 170). The testing conduc…	Howmedica Osteonics Corp.	2007	1
*	K093644	Restoration Adm System X3 Acetabular Summary page 2 …rate equivalence of the subject device compared to its predicate device. Predicate devices include Restoration® ADM System (K072020), Restoration® X3® Acetabular Insert (K093644), and Trident® Porous Titanium Acetabular Component (KO010 170). The testing conducted includes disassembly force evaluation incl…	Howmedica Osteonics Corp.	2009	1
*	K010170	Trident Porous Titanium Acetabular Component	Howmedica Osteonics Corp.	2001	—

Also cleared against K072020: 9 other devices →

What descends from it? (52)

See all 52

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

Number	Device	Applicant	Decided	Descendants
K150522	G7 Dual Mobility System	Biomet, Inc.	2015	21
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17
K170359	Trinity™ Dual Mobility System	Corin U.S.A. Limited	2017	10
K112556	Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts	Howmedica Osteonics Corp.	2011	10
K200854	DePuy PINNACLE Dual Mobility Liner	Depuy Ireland UC	2020	7
K182468	Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	2019	7
K131458	Mpact DM Liner Converter	Medacta International	2013	3
K220495	SignaSure Dual Mobility System	Signature Orthopaedics Pty, Ltd.	2023	1
K200607	LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters	Waldemar Link GmbH & Co. KG	2021	1
K243456	ONVOY™ Acetabular System	Globus Medical, Inc.	2025	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 3, 2011	Not classified	Z-0192-2012	Labeling False and Misleading	Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K150522 (Biomet, Inc., 2015) has gone furthest, with 21 descendants of its own.
9 other devices also cite its predicate K072020.

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. 2011, this device’s year, is highlighted.

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	—

What is it indicated for?

The indications for use of the total hip arthroplasty include:

1) Noninflammatory degenerative joint disease including osteoarthiritis and avascular necrosis;

2) Rheumatoid arthritis

3) Correction of functional deformity;

4) Revision procedures where other treatments or devices have failed;

5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

6) Dislocation risks

The MDMTM1 liners are intended for cementless use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103233 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103233: Modular Dual Mobility Liner, X3 Acetabular Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103233

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026