510(k) Report

510(k) · Cleared

Cleared

Aml Hip Prosthesis

K003800510(k) TraditionalCleared Feb 9, 200163-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Feb 9, 2001 as substantially equivalent to K931641 (Depuy, Inc., 1994) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1994. 159 later devices descend from it.

Decided
Feb 9, 2001
Review
63 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K931641 (1994). 2 ancestors in all. 159 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor2001: 1 descendant cleared2003: 2 descendants cleared2006: 3 descendants cleared2008: 2 descendants cleared2004: 2 descendants cleared2024: 14 descendants cleared2013: 5 descendants cleared2012: 6 descendants cleared2005: 2 descendants cleared2010: 6 descendants cleared2014: 8 descendants cleared2009: 1 descendant cleared2018: 7 descendants cleared2007: 1 descendant cleared2016: 6 descendants cleared2015: 5 descendants cleared2017: 8 descendants cleared2025: 14 descendants cleared2019: 14 descendants cleared2022: 12 descendants cleared2026: 14 descendants cleared2020: 6 descendants cleared2023: 13 descendants cleared2021: 7 descendants clearedK931641 · Porocoat Porous Coating · Depuy, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 21 descendants5 generations forward: 33 descendants6 generations forward: 29 descendants7 generations forward: 34 descendants8 generations forward: 19 descendants9 generations forward: 7 descendants10 generations forward: 1 descendant K931641 · Porocoat Porous Coating · Depuy, Inc. · 19940+5+10
  1. Root · 1 generation backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
  2. This deviceK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  3. Descendant · cites it directly · 158 of its ownK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  4. Descendant · cites it directly · 146 of its ownK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
  5. Descendant · 2 generations on · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
  6. Descendant · 3 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
  7. Descendant · 3 generations on · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled

Showing 5 of 159 descendants. See all descendants

Descendants cleared per year

2001: 12003: 22004: 22005: 22006: 32007: 12008: 22009: 12010: 62012: 62013: 52014: 82015: 52016: 62017: 82018: 72019: 142020: 62021: 72022: 122023: 132024: 142025: 142026: 14
2001high 14 (2019) · low 0 (2002)2026

Most influential descendants

Showing 5 of 159 · See all
  • K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001 · cites it directly158descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931641Porocoat Porous CoatingDepuy, Inc.1994—
0 (this device)K003800Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
+1K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
+1K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003—
+2K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041
+3K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.2004—
+3K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.200512

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200320
200420
200520
200630
200710
200820
200910
201060
201260
201350
201480
201550
201660
201780
201870
2019140
202060
202170
2022120
2023130
2024140
2025140
2026140
FIG. 1 — Lineage of K003800, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K931641Porocoat Porous Coating
Summary page 1
…CosmeticAct for femoralhip stems. PorocoatoProdi&Fm Substantially Equivalent Device: Hip ProsthesisK931641 Vision AMO Hip Prosthesis K953694 DeviceDescriptions: The AML hip…
Depuy, Inc.1994—
*K953694Depuy Vision Aml Hip Prothesis
Summary page 1
…PorocoatoProdi&Fm Substantially Equivalent Device: Hip ProsthesisK931641 Vision AMO Hip Prosthesis K953694 DeviceDescriptions: The AML hip stemismanufactured from ASTM Cobalt…
Depuy, Inc.1996—

Also cleared against K931641: 4 other devices →

What descends from it? (159)

See all 159

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001158
K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003146

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K012364 (DePuy Orthopaedics, Inc., 2001) has gone furthest, with 158 descendants of its own.
  • 4 other devices also cite its predicate K931641.

How does its category compare?

All LPH devices

LPH 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

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

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 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.

Also cleared against K931641

4 other devices cite the same predicate.

  • K014070Epoch Hip Prosthesis, Model 4075 SeriesZimmer, Inc. · 2002
  • K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  • K000207Porocoat Prodigy Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
  • K973714Versys Hip System Beaded Hip ProsthesisZimmer, Inc. · 19978 recalls

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K003800 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003800: Aml Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003800

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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