510(k) · Cleared
Recalled · Class II · 2012Pinnacle 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 Mar 23, 2000 as substantially equivalent to K983014 (Johnson & Johnson Professionals, Inc., 1998) after a 51-day review. Its family tree reaches back 2 generations to 1993. 403 later devices descend from it. It has been recalled once.
- Decided
- Mar 23, 2000
- Review
- 51 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930712 (1993). 6 ancestors in all. 403 later devices descend from it, 18 citing it directly.
- Root · 2 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 1 generation backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- This deviceK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- Descendant · cites it directly · 267 of its ownK001534 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 · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- Descendant · 2 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 118 of its ownK040544 Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066…Depuy, Inc. · 2004
Showing 5 of 403 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 403 · See all- K001534Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · cites it directly267descendants
- K031110Apex Modular Acetabular CupApex Surgical, LLC · 2003 · cites it directly217descendants
- K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · cites it directly207descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
- K040544Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…Depuy, Inc. · 2004 · 2 generations on118descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −1 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| 0 (this device) | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| +1 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| +1 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| +1 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| +2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +2 | K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044… | Depuy, Inc. | 2004 | — |
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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 10 | 0 |
| 2009 | 8 | 0 |
| 2010 | 15 | 0 |
| 2011 | 17 | 0 |
| 2012 | 30 | 0 |
| 2013 | 26 | 0 |
| 2014 | 16 | 0 |
| 2015 | 14 | 0 |
| 2016 | 19 | 0 |
| 2017 | 23 | 0 |
| 2018 | 23 | 0 |
| 2019 | 25 | 0 |
| 2020 | 21 | 0 |
| 2021 | 23 | 0 |
| 2022 | 26 | 0 |
| 2023 | 26 | 0 |
| 2024 | 18 | 0 |
| 2025 | 29 | 0 |
| 2026 | 19 | 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 |
|---|---|---|---|
| * | K983014 | Summit Acetabular SystemSummary page 1…The PinnacleAcetabularSystem has thefollowingsimilarities totheacetabularcup liners thatwere clearedinK983014: same intendeduse; same material;same method of manufacture;same design;same sterilization… | 1998 |
What descends from it? (403)
See all 40318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K001534 | Pinnacle Acetabular System | 2000 | 267 |
| K031110 | Apex Modular Acetabular Cup | 2003 | 217 |
| K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | 2003 | 207 |
| K062148 | Depuy Pinnacle Altrx Acetabular Cup Liner | 2006 | 106 |
| K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series… | 2012 | 20 |
| K120924 | Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw… | 2012 | 8 |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | 2019 | 6 |
| K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | 2016 | 6 |
| K172857 | Latitud Hip Replacement System | 2018 | 5 |
| K172806 | Bencox Mirabo Cup System | 2017 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2012 | Class II | Z-0569-2013 | Labeling Change Control | DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous… |
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 5.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K001534 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 267 descendants of its own.
- 1 other device also cites its predicate K983014.
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 Acetabular System 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 arthritis, 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…
Read the full statement (95 words)
The Pinnacle Acetabular System 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 arthritis, 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.
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/K000306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000306: 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/K000306
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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