510(k) · Cleared
ClearedTCP-Coated Porocoat Aml Femoral Hip Prosthesis
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 Jun 19, 1997 as substantially equivalent to K941847 (Depuy, Inc., 1994) and 1 other predicate after a 211-day review. Its family tree reaches back 1 generation to 1994. 311 later devices descend from it.
- Decided
- Jun 19, 1997
- Review
- 211 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941847 (1994). 2 ancestors in all. 311 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- This deviceK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- Descendant · cites it directly · 309 of its ownK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 296 of its ownK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · 2 generations on · 213 of its ownK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- Descendant · 3 generations on · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
Showing 5 of 311 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 311 · See all- K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 1998 · cites it directly309descendants
- K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · 2 generations on296descendants
- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 3 generations on267descendants
- K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000 · 2 generations on213descendants
- K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · 3 generations on207descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| 0 (this device) | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| +1 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| +2 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| +3 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +2 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| +3 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 16 | 0 |
| 2012 | 26 | 0 |
| 2013 | 23 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 11 | 0 |
| 2017 | 17 | 0 |
| 2018 | 17 | 0 |
| 2019 | 15 | 0 |
| 2020 | 16 | 0 |
| 2021 | 19 | 0 |
| 2022 | 18 | 0 |
| 2023 | 20 | 0 |
| 2024 | 16 | 0 |
| 2025 | 22 | 0 |
| 2026 | 20 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P820024 | Prosthesis, Hip, Hemi-Femoral, Metal FDA lists this PMA only through its supplements; the earliest we hold is P820024/S001 (Mar 16, 1984). Summary page 1…: Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous Uncemented, Calcium-Phosphate SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Inc. AML® % Porocoat® Femoral Implant (P820024, K941847) INTENDED USE AND DEVICE DESCRIPTION: The primary objective of total hip arthroplasty in general is to provide for incr… | |
| * | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous CoatingSummary page 1…sis, Hip, Semi-constrained, Metal/Polymer, Porous Uncemented, Calcium-Phosphate SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Inc. AML® % Porocoat® Femoral Implant (P820024, K941847) INTENDED USE AND DEVICE DESCRIPTION: The primary objective of total hip arthroplasty in general is to provide for increased mob… | 1994 |
What descends from it? (311)
See all 3112 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?
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?
The TCP-coated Porocoat® AML® Femoral Hip Prosthesis, with an appropriate Co-Cr-Mo alloy metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating. This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for…
Read the full statement (138 words)
The TCP-coated Porocoat® AML® Femoral Hip Prosthesis, with an appropriate Co-Cr-Mo alloy metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.
This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for total hip replacement in the following indications, as appropriate:
1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
5. Certain cases of ankylosis.
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/K964650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964650: TCP-Coated Porocoat Aml Femoral 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/K964650
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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