510(k) · Cleared
Recalled · Class II · 2012Depuy Pinnacle Altrx Acetabular Liners
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 Oct 29, 2010 as substantially equivalent to K072963 (DePuy Orthopaedics, Inc., 2008) after a 65-day review. Its family tree reaches back 5 generations to 1993. 17 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 29, 2010
- Review
- 65 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930712 (1993). 11 ancestors in all. 17 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 4 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 2 generations backK062148 Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc. · 2006
- 1 generation backK072963 Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc. · 2008
- This deviceK102423 Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc. · 2010
- Descendant · cites it directly · 13 of its ownK132959 Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc. · 2014
- Descendant · 2 generations on · 7 of its ownK221636 EMPHASYS Acetabular SystemDepuy Ireland UC · 2022
- Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · cites it directly · 4 of its ownK183582 MPACT ExtensionMedacta International S.A. · 2019
- Descendant · 2 generations on · 3 of its ownK230011 Mpact ExtensionMedacta International S.A. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K132959Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc. · 2014 · cites it directly13descendants
- K221636EMPHASYS Acetabular SystemDepuy Ireland UC · 2022 · 2 generations on7descendants
- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
- K183582MPACT ExtensionMedacta International S.A. · 2019 · cites it directly4descendants
- K230011Mpact ExtensionMedacta International S.A. · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −4 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −2 | K062148 | Depuy Pinnacle Altrx Acetabular Cup Liner | DePuy Orthopaedics, Inc. | 2006 | — |
| −1 | K072963 | Depuy Pinnacle Altrx Acetabular Liners | DePuy Orthopaedics, Inc. | 2008 | — |
| 0 (this device) | K102423 | Depuy Pinnacle Altrx Acetabular Liners | DePuy Orthopaedics, Inc. | 2010 | — |
| +1 | K132959 | Depuy Pinnacle Altrx Acetabular Liners | DePuy Orthopaedics, Inc. | 2014 | — |
| +2 | K221636 | EMPHASYS Acetabular System | Depuy Ireland UC | 2022 | — |
| +1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +1 | K183582 | MPACT Extension | Medacta International S.A. | 2019 | — |
| +2 | K230011 | Mpact Extension | Medacta International S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K072963 | Depuy Pinnacle Altrx Acetabular LinersSummary page 1…Porous, Uncemented PREDICATE DEVICES DePuy Pinnacle AltrX Acetabular Liners (K072963, cleared January 9, 2008) DEVICE DESCRIPTION: The DePuy Pinnacle AltrX Acetabular Liners are pant of a modular system designed t… | 2008 |
What descends from it? (17)
See all 174 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2012 | Class II | Z-2220-2012 | Employee error | In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner. |
| Mar 7, 2012 | Class II | Z-1366-2013 | Packaging process control | DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K132959 (DePuy Orthopaedics, Inc., 2014) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K072963.
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. 2010, this device’s year, is highlighted.
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 AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures. 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…
Read the full statement (100 words)
The DePuy Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures.
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, hemniarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cemnentless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102423: Depuy Pinnacle Altrx Acetabular Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102423
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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