510(k) · Cleared
ClearedDepuy Vision Aml Hip Prothesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 1, 1996 after a 177-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 283 later devices descend from it.
- Decided
- Feb 1, 1996
- Review
- 177 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
283 later devices descend from it, 5 citing it directly.
- This deviceK953694 Depuy Vision Aml Hip ProthesisDepuy, Inc. · 1996
- Descendant · cites it directly · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- Descendant · cites it directly · 159 of its ownK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- Descendant · cites it directly · 158 of its ownK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- Descendant · 2 generations on · 146 of its ownK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
Showing 5 of 283 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 283 · See all- K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000 · cites it directly188descendants
- K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · 2 generations on168descendants
- K003800Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001 · cites it directly159descendants
- K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001 · cites it directly158descendants
- K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003 · 2 generations on146descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953694 | Depuy Vision Aml Hip Prothesis | Depuy, Inc. | 1996 | — |
| +1 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| +2 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| +1 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| +1 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| +2 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 10 | 0 |
| 2013 | 16 | 0 |
| 2014 | 10 | 0 |
| 2015 | 8 | 0 |
| 2016 | 12 | 0 |
| 2017 | 17 | 0 |
| 2018 | 17 | 0 |
| 2019 | 23 | 0 |
| 2020 | 18 | 0 |
| 2021 | 12 | 0 |
| 2022 | 19 | 0 |
| 2023 | 21 | 0 |
| 2024 | 19 | 0 |
| 2025 | 23 | 0 |
| 2026 | 19 | 0 |
Sources: FDA 510(k) database (decision fields), 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 24.3 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (283)
See all 2835 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?
- Of its descendants, K001991 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 188 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K953694 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953694: Depuy Vision Aml Hip Prothesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953694
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026