510(k) · Cleared
ClearedAml Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Oct 19, 2001 as substantially equivalent to K931641 (Depuy, Inc., 1994) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1994. 158 later devices descend from it.
- Decided
- Oct 19, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931641 (1994). 3 ancestors in all. 158 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 1 generation backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- This deviceK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- Descendant · cites it directly · 146 of its ownK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- Descendant · 2 generations on · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- Descendant · 3 generations on · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 59 of its ownK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
Showing 5 of 158 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 158 · See all- K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003 · cites it directly146descendants
- K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · 2 generations on145descendants
- K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · 3 generations on64descendants
- K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · 3 generations on60descendants
- K070479Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · 4 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −1 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| 0 (this device) | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| +1 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| +2 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| +3 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| +3 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| +4 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 14 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 13 | 0 |
| 2024 | 14 | 0 |
| 2025 | 14 | 0 |
| 2026 | 14 | 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 24.3 · 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? (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 |
|---|---|---|---|
| * | K931641 | Porocoat Porous CoatingSummary page 1…been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems. Substantially Equivalent Device: Porocoat® Prodigy™ Hip Prosthesis K931641 Vision AML® Hip Prosthesis K953694 AML Hip Prosthesis K003800 Device Descriptions: The AML hip stem is manufactured from ASTM F-… | 1994 |
| * | K953694 | Depuy Vision Aml Hip ProthesisSummary page 1…of the Federal Food, Drug, and Cosmetic Act for femoral hip stems. Substantially Equivalent Device: Porocoat® Prodigy™ Hip Prosthesis K931641 Vision AML® Hip Prosthesis K953694 AML Hip Prosthesis K003800 Device Descriptions: The AML hip stem is manufactured from ASTM F- 75 Cobalt-Chromium-Molybdenum allo… | 1996 |
| * | K003800 | Aml Hip ProsthesisSummary page 1…and Cosmetic Act for femoral hip stems. Substantially Equivalent Device: Porocoat® Prodigy™ Hip Prosthesis K931641 Vision AML® Hip Prosthesis K953694 AML Hip Prosthesis K003800 Device Descriptions: The AML hip stem is manufactured from ASTM F- 75 Cobalt-Chromium-Molybdenum alloy and has a sintered cobalt… | 2001 |
What descends from it? (158)
See all 1584 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 7 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030236 (Exactech, Inc., 2003) has gone furthest, with 146 descendants of its own.
- 4 other devices also cite its predicate K931641.
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 | — |
What is it indicated for?
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. Avascular necrosis of…
Read the full statement (145 words)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.
The AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prostheses to the bone cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012364: Aml Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012364
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026