510(k) · Cleared
ClearedDePuy PINNACLE Dual Mobility Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Sep 11, 2020 as substantially equivalent to K103233 (Howmedica Osteonics Corp., 2011) after a 164-day review. Its family tree reaches back 2 generations to 2001. 7 later devices descend from it.
- Decided
- Sep 11, 2020
- Review
- 164 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010170 (2001). 4 ancestors in all. 7 later devices descend from it, 2 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 deviceK200854 DePuy PINNACLE Dual Mobility LinerDepuy Ireland UC · 2020
- Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 2 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
- Descendant · 2 generations on · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- Descendant · 3 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
- Descendant · 3 generations on · 0 of its ownK252067 Velora Acetabular SystemRestor3D, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
- K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 2 generations on1descendant
- K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · 2 generations on1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 3 generations on0descendants
- K252067Velora Acetabular SystemRestor3D, Inc. · 2025 · 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) | K200854 | DePuy PINNACLE Dual Mobility Liner | Depuy Ireland UC | 2020 | — |
| +1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +2 | K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025 | — |
| +2 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| +3 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +3 | K252067 | Velora Acetabular System | Restor3D, Inc. | 2025 | — |
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 |
|---|---|---|
| 2024 | 3 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K103233 | Modular Dual Mobility Liner, X3 Acetabular InsertSummary page 4…21 CFR 888.3358, 888.3353 Product Code(s) LPH, LZO, MEH Legally marketed device(s) to Stryker Modular Dual Mobility (MDM) Liner (K103233, cleared February 3, which equivalence is claimed 2011) Reference device: BI-MENTUM Dual Mobil… | 2011 |
| † | K181744 | BI-MENTUM dual mobility system | 2018 |
What descends from it? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; 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, K231873 (Depuy Ireland UC, 2024) has gone furthest, with 5 descendants of its own.
- 10 other devices also cite its predicate K103233.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease).
2. Failed previous hip surgery.
3. Dislocation risks.
PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200854: DePuy PINNACLE Dual Mobility Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200854
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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