510(k) · Cleared
ClearedDepuy Aml 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 Jul 17, 2006 as substantially equivalent to K012364 (DePuy Orthopaedics, Inc., 2001) and 2 other predicates after an 18-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jul 17, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K931641 (1994). 10 ancestors in all, the oldest K900638 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 4 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 3 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 2 generations backK030979 Modification to Depuy Solution System Hip ProsthesisDePuy Orthopaedics, Inc. · 2003
- 1 generation backK060581 Depuy Solution System Hip ProsthesisDePuy Orthopaedics, Inc. · 2006 · Recalled
- This deviceK061833 Depuy Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −4 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −3 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −2 | K030979 | Modification to Depuy Solution System Hip Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K060581 | Depuy Solution System Hip Prosthesis | DePuy Orthopaedics, Inc. | 2006 | 20 |
| 0 (this device) | K061833 | Depuy Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 2001 | 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 24.3 · 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 |
|---|---|---|---|
| * | K012364 | Aml Hip ProsthesisSummary page 1…-constrained porous coated uncemented prosthesis, Class II Device DEVICE PRODUCT CODE: 87 LPH SUBSTANTIALLY EQUIVALENT DEVICES: DePuy AMI? Hip Prosthesis (K012364, cleared October 19, 2001) DePuy Solution System® Hip Prosthesis (K0605 £1, cleared May 19, 2006) DePuy Vision Solution Hip Prost… | 2001 |
| * | K060581 | Depuy Solution System Hip ProsthesisSummary page 2…ign, DePuy believes that the AML® Hip Prosthesis is substantially equivalent to the FDA-cleared DePuy AML® Hip Prosthesis (K012364), the Solation System® Hip Prosthesis (K060581) and the Vision Solution® Hip Prosthesis (K953703). I1A… | 2006 |
| * | K953703 | Depuy Vision Solution Hip ProsthesisSummary page 1…ePuy AMI? Hip Prosthesis (K012364, cleared October 19, 2001) DePuy Solution System® Hip Prosthesis (K0605 £1, cleared May 19, 2006) DePuy Vision Solution Hip Prosthesis (K953703, cleared February 1, 1996) DEVICE DESCRIPTION: The subject device, DePuy AML® Hip Prosthesi:!:, is manufactured from ASTM F-799… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 3 other devices also cite its predicate K012364.
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. 2. Avascular necrosis…
Read the full statement (149 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.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The AML® Hip Stem is indicated for cementless use with 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 prosthesis to the bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061833: Depuy 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/K061833
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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