510(k) · Cleared

Recalled · 2011

Restoration Adm System X3 Acetabular

K093644510(k) SpecialCleared Dec 18, 200923-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. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on Dec 18, 2009 after a 23-day review. The FDA summary names no predicate by number. 57 later devices descend from it. It has been recalled once.

Decided: Dec 18, 2009
Review: 23 days
Class: Class II
Product code: MEH
Recalls: 1
Predicates: 0

57 later devices descend from it, 7 citing it directly.

This deviceK093644 Restoration Adm System X3 AcetabularHowmedica Osteonics Corp. · 2009
Descendant · cites it directly · 52 of its ownK103233 Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp. · 2011 · Recalled
Descendant · cites it directly · 24 of its ownK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
Descendant · 2 generations on · 22 of its ownK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
Descendant · 2 generations on · 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

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2011high 9 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 57 · See all

K103233Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp. · 2011 · cites it directly52descendants
K101336E1 Avantage HeadBiomet Manufacturing Corp · 2011 · cites it directly24descendants
K110555Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · 2 generations on22descendants
K150522G7 Dual Mobility SystemBiomet, Inc. · 2015 · 2 generations on21descendants
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K093644	Restoration Adm System X3 Acetabular	Howmedica Osteonics Corp.	2009	—
+1	K103233	Modular Dual Mobility Liner, X3 Acetabular Insert	Howmedica Osteonics Corp.	2011	1
+1	K101336	E1 Avantage Head	Biomet Manufacturing Corp	2011	1
+2	K110555	Arcomxl Active Articulation	Biomet Manufacturing Corp	2011	2
+2	K150522	G7 Dual Mobility System	Biomet, Inc.	2015	1
+1	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	4	0
2012	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	7	0
2023	3	0
2024	7	0
2025	9	0
2026	4	0

FIG. 1 — Lineage of K093644, 2009–2026Source: 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 MEH? 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 MEH device

#1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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?

The FDA summary names no predicate by number.

What descends from it? (57)

See all 57

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

Number	Device	Applicant	Decided	Descendants
K103233	Modular Dual Mobility Liner, X3 Acetabular Insert	Howmedica Osteonics Corp.	2011	52
K101336	E1 Avantage Head	Biomet Manufacturing Corp	2011	24
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17
K112556	Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts	Howmedica Osteonics Corp.	2011	10
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
K211742	SignaSure Dual Mobility System	Signature Orthopaedics Pty, Ltd.	2022	2
K220495	SignaSure Dual Mobility System	Signature Orthopaedics Pty, Ltd.	2023	1

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-0193-2012	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?

Of its descendants, K103233 (Howmedica Osteonics Corp., 2011) has gone furthest, with 52 descendants of its own.

How does its category compare?

All MEH devices

MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MEH

5in 2025

2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEH

87in 2025

2007high 226 (2010) · low 65 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MEH

1in 2025

2007high 80 (2008) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MEH

470in 2025

2007high 1,606 (2012) · low 25 (2007)2025

MAUDE reports naming product code MEH, 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	2	—	3	25
2008	6	79	80	261
2009	6	65	51	539
2010	5	226	16	462
2011	5	95	4	419
2012	6	131	3	1,606
2013	1	—	0	1,295
2014	0	—	1	1,196
2015	2	—	1	490
2016	6	163	4	347
2017	3	209	1	383
2018	2	—	3	337
2019	1	—	0	335
2020	3	131	1	338
2021	3	83	0	372
2022	3	150	0	316
2023	2	—	0	334
2024	6	91	0	354
2025	5	87	1	470
2026	1	—	1	—

What is it indicated for?

The indications for use of the total hip arthroplasty include:

1) Noninflammatory degenerative joint disease including osteoarthritis 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

This acetabular cup is intended for cementless use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093644 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093644: Restoration Adm System X3 Acetabular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093644

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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