510(k) · Cleared
ClearedPinnacle Duofix HA Acetabular Cup 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 Jun 11, 2003 as substantially equivalent to K000306 (DePuy Orthopaedics, Inc., 2000) and 1 other predicate after a 29-day review. Its family tree reaches back 4 generations to 1994. 207 later devices descend from it.
- Decided
- Jun 11, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K941847 (1994). 18 ancestors in all, the oldest K840643 (1984). 207 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 3 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 2 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 1 generation backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- This deviceK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- Descendant · cites it directly · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 2 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 2 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 2 generations on · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
Showing 5 of 207 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 207 · See all- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · cites it directly198descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 2 generations on90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 2 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 2 generations on83descendants
- K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · 2 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −3 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −2 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −1 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| +1 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +2 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +2 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +2 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 11 | 0 |
| 2012 | 16 | 0 |
| 2013 | 12 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 17 | 0 |
| 2022 | 13 | 0 |
| 2023 | 15 | 0 |
| 2024 | 11 | 0 |
| 2025 | 19 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K000306 | Pinnacle Acetabular SystemSummary page 2…s, and the same intended use, DePuy believes that the Pinnacle Duofix HA Acetabular Cup is substantially equivalent to the previously cleared Pinnacle Acetabular System, K000306. In addition, DePuy believes that the hydroxyapatite (HA) coating applied to the Pinnacle Duofix HA Acetabular Cup Prosthesis is… | 2000 |
| * | K001277 | Triflange Acetabular Cup System | 2000 |
What descends from it? (207)
See all 2075 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042344 | Excia Total Hip System | 2005 | 198 |
| K121777 | U2 Acetabular Cup, Plasma Spray | 2012 | 9 |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | 2019 | 6 |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner… | 2016 | 4 |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | 2024 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K042344 (Aesculap, Inc., 2005) has gone furthest, with 198 descendants of its own.
- 17 other devices also cite its predicate K000306.
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 Pinnacle DuofixTMHA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthtis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with…
Read the full statement (99 words)
The Pinnacle DuofixTMHA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthtis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031495
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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