510(k) · Cleared
ClearedPinnacle Acetabular System
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 12, 2000 as substantially equivalent to K000306 (DePuy Orthopaedics, Inc., 2000) after a 26-day review. Its family tree reaches back 3 generations to 1993. 267 later devices descend from it.
- Decided
- Jun 12, 2000
- Review
- 26 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930712 (1993). 7 ancestors in all. 267 later devices descend from it, 15 citing it directly.
- Root · 3 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 2 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 1 generation backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- This deviceK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- Descendant · cites it directly · 217 of its ownK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- Descendant · cites it directly · 118 of its ownK040544 Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066…Depuy, Inc. · 2004
- Descendant · cites it directly · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 2 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · cites it directly · 72 of its ownK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
Showing 5 of 267 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 267 · See all- K031110Apex Modular Acetabular CupApex Surgical, LLC · 2003 · cites it directly217descendants
- K040544Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…Depuy, Inc. · 2004 · cites it directly118descendants
- K093472Trinity Acetabular SystemCorin USA · 2010 · cites it directly117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 2 generations on109descendants
- K071784Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007 · cites it directly72descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −2 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −1 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| 0 (this device) | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| +1 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| +1 | K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044… | Depuy, Inc. | 2004 | — |
| +1 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +1 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 8 | 0 |
| 2012 | 17 | 0 |
| 2013 | 19 | 0 |
| 2014 | 10 | 0 |
| 2015 | 12 | 0 |
| 2016 | 13 | 0 |
| 2017 | 15 | 0 |
| 2018 | 18 | 0 |
| 2019 | 21 | 0 |
| 2020 | 15 | 0 |
| 2021 | 14 | 0 |
| 2022 | 19 | 0 |
| 2023 | 20 | 0 |
| 2024 | 12 | 0 |
| 2025 | 23 | 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 24.2 · 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? (1)
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 1…appropriate diameter. BASIS OF SUBSTANTIAL EQUIVALENCE: The Pinnacle Acetabular System has the following similarities to the acetabular cup liners that were cleared in K000306: same intended use; same material; same method of manufacture; same design; same sterilization and packaging methods. The Pinnacl… | 2000 |
What descends from it? (267)
See all 26715 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031110 | Apex Modular Acetabular Cup | 2003 | 217 |
| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062… | 2004 | 118 |
| K093472 | Trinity Acetabular System | 2010 | 117 |
| K071784 | Depuy Pinnacle with Gripton Acetabular Cups | 2007 | 72 |
| K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | 2009 | 48 |
| K100933 | Consensus CS2 Plus Acetabular Insert | 2010 | 35 |
| K130128 | Trinity Acetabular System | 2013 | 17 |
| K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | 2012 | 12 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | 2024 | 5 |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner… | 2016 | 4 |
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 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K031110 (Apex Surgical, LLC, 2003) has gone furthest, with 217 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 DePuy Pinnacle Acetabular System is intended to be used to resurface the acetabular socket in cemented or cementless total hip arthroplasty. The Pinnacle Acetabular System is indicated for total hip replacement 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…
Read the full statement (103 words)
The DePuy Pinnacle Acetabular System is intended to be used to resurface the acetabular socket in cemented or cementless total hip arthroplasty.
The Pinnacle Acetabular System is indicated for total hip replacement 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, herniarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain casesof ankylosis.
All Pinnacle porous-coated acetabular shells are indicated for cementless application.
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/K001534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001534: Pinnacle Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001534
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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