510(k) · Cleared
Recalled · 2011Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Sep 28, 2011 as substantially equivalent to K072020 (Howmedica Osteonics Corp., 2007) and 2 other predicates after a 26-day review. Its family tree reaches back 2 generations to 2001. 10 later devices descend from it. It has been recalled once.
- Decided
- Sep 28, 2011
- Review
- 26 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010170 (2001). 4 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK010170 Trident Porous Titanium Acetabular ComponentHowmedica Osteonics Corp. · 2001
- 1 generation backK103233 Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp. · 2011 · Recalled
- This deviceK112556 Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 InsertsHowmedica Osteonics Corp. · 2011
- Descendant · cites it directly · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
- Descendant · 2 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 3 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · cites it directly · 1 of its ownK220495 SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · cites it directly7descendants
- K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
- K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 3 generations on2descendants
- K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2023 · cites it directly1descendant
- K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010170 | Trident Porous Titanium Acetabular Component | Howmedica Osteonics Corp. | 2001 | — |
| −1 | K103233 | Modular Dual Mobility Liner, X3 Acetabular Insert | Howmedica Osteonics Corp. | 2011 | 1 |
| 0 (this device) | K112556 | Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts | Howmedica Osteonics Corp. | 2011 | — |
| +1 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II… | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
| +2 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +3 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +1 | K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2023 | — |
| +3 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | 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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K072020 | Restoration Adm SystemSummary page 2…The ADM and MDM Systems are intended for cementless use only. Devices for which Suhstantial Equivalence is claimed: " Howmedica Osteonics Restoration® ADM System: K072020 " Howmedica Osteonics Restoration® ADM X3' Acetabular Insert: K093644 * Howmedica Osteonics Restoration MDM System: K10… | 2007 |
| * | K093644 | Restoration Adm System X3 AcetabularSummary page 2…which Suhstantial Equivalence is claimed: " Howmedica Osteonics Restoration® ADM System: K072020 " Howmedica Osteonics Restoration® ADM X3' Acetabular Insert: K093644 * Howmedica Osteonics Restoration MDM System: K103233 Proposed Modification: The subject ADM Inserts and ADMIMDM Inserts ma… | 2009 |
| * | K103233 | Modular Dual Mobility Liner, X3 Acetabular InsertSummary page 2…Osteonics Restoration® ADM System: K072020 " Howmedica Osteonics Restoration® ADM X3' Acetabular Insert: K093644 * Howmedica Osteonics Restoration MDM System: K103233 Proposed Modification: The subject ADM Inserts and ADMIMDM Inserts maintain the same indications for and intended use, material,… | 2011 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2011 | Not classified | Z-0931-2012 | Packaging | As part of Stryker's quality process, a packaging discrepancy was identified in specific lots of Stryker's Duration packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 9.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K182468 (Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, 2019) has gone furthest, with 7 descendants of its own.
- 9 other devices also cite its predicate K072020.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 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 for 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
The ADM and MDN4 Systems are intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112556: Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112556
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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