510(k) · Cleared
Recalled · 2011Restoration Adm System
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 Oct 18, 2007 after an 87-day review. The FDA summary names its predicate without a number. 95 later devices descend from it. It has been recalled once.
- Decided
- Oct 18, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 0
95 later devices descend from it, 10 citing it directly.
- This deviceK072020 Restoration Adm SystemHowmedica Osteonics Corp. · 2007
- Descendant · cites it directly · 59 of its ownK083116 Versafit Cup Double Mobility SystemMedacta International S.A. · 2009 · Recalled
- Descendant · cites it directly · 52 of its ownK103233 Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp. · 2011 · Recalled
- Descendant · cites it directly · 27 of its ownK111572 Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH…Serf · 2011 · Recalled
- Descendant · cites it directly · 24 of its ownK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- Descendant · 2 generations on · 23 of its ownK092265 Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · See all- K083116Versafit Cup Double Mobility SystemMedacta International S.A. · 2009 · cites it directly59descendants
- K103233Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp. · 2011 · cites it directly52descendants
- K111572Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Serf · 2011 · cites it directly27descendants
- K101336E1 Avantage HeadBiomet Manufacturing Corp · 2011 · cites it directly24descendants
- K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072020 | Restoration Adm System | Howmedica Osteonics Corp. | 2007 | — |
| +1 | K083116 | Versafit Cup Double Mobility System | Medacta International S.A. | 2009 | 2 |
| +1 | K103233 | Modular Dual Mobility Liner, X3 Acetabular Insert | Howmedica Osteonics Corp. | 2011 | 1 |
| +1 | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back)… | Serf | 2011 | 5 |
| +1 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
| +2 | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | Medacta International S.A. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 3 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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? (4)
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 |
|---|---|---|---|
| * | — | Trident® Acetabular System Named without a submission number | |
| * | — | Biomet Tri-Polar System Named without a submission number | |
| * | — | Plus Orthopaedics Ag Polarcup Dual Mobility System Named without a submission number | |
| * | — | UHR Bipolar System Named without a submission number |
What descends from it? (95)
See all 9510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083116 | Versafit Cup Double Mobility System | 2009 | 59 |
| K103233 | Modular Dual Mobility Liner, X3 Acetabular Insert | 2011 | 52 |
| K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH… | 2011 | 27 |
| K101336 | E1 Avantage Head | 2011 | 24 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K112556 | Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts | 2011 | 10 |
| K171273 | LINK® BiMobile (TM) Dual Mobility System | 2018 | 4 |
| K211742 | SignaSure Dual Mobility System | 2022 | 2 |
| K220495 | SignaSure Dual Mobility System | 2023 | 1 |
| K111981 | Tregor Dual Mobility Acetabular System | 2012 | 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-0194-2012 | 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, K083116 (Medacta International S.A., 2009) has gone furthest, with 59 descendants of its own.
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. 2007, 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 of the total hip replacement prostheses 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 trochanterie 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/K072020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072020: Restoration Adm System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072020
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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