510(k) · Cleared
ClearedDepuy Pinnacle Altrx Acetabular Cup Liner
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 24, 2006 as substantially equivalent to K033273 (DePuy Orthopaedics, Inc., 2004) and 2 other predicates after an 89-day review. Its family tree reaches back 3 generations to 1993. 106 later devices descend from it.
- Decided
- Oct 24, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K930712 (1993). 9 ancestors in all. 106 later devices descend from it, 8 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 deviceK062148 Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 62 of its ownK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
- Descendant · 2 generations on · 34 of its ownK100555 Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- Descendant · 2 generations on · 24 of its ownK101575 Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models…Omnlife Science · 2010
- Descendant · 3 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008 · cites it directly62descendants
- K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · 2 generations on34descendants
- K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · 2 generations on25descendants
- K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science · 2010 · 2 generations on24descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 3 generations on21descendants
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) | K062148 | Depuy Pinnacle Altrx Acetabular Cup Liner | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K073150 | Apex-LNK Poly Acetabular Cup Liners | Omni Life Science, Inc. | 2008 | — |
| +2 | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK | Omni Life Science, Inc. | 2010 | 1 |
| +2 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| +2 | K101575 | Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810… | Omnlife Science | 2010 | — |
| +3 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 11 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 0 |
| 2026 | 9 | 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? (3)
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 |
|---|---|---|---|
| * | K033273 | Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima…Summary page 1…87 LPH, LZO SUBSTANTIALLY EQUIVALENT DEVICE: DePuy Pinnacle® Acetabular Cup System ESL Marathon TM Polyethylene liners (K03 3273, cleared May 6, 2004) DePuy Pinnacle® Acetabular System (K000306… | 2004 |
| * | K000306 | Pinnacle Acetabular SystemSummary page 1…Marathon TM Polyethylene liners (K03 3273, cleared May 6, 2004) DePuy Pinnacle® Acetabular System (K000306, cleared March 23, 2000) Wright Medical LINEAGE® A-… | 2000 |
| * | K052026 | Lineage a-Class Poly LinerSummary page 1…cleared March 23, 2000) Wright Medical LINEAGE® A-CLASS TM Poly Liner (K052026, cleared Dec 5, 2005) DEVICE INFORMATION: A. DEVICE DESCRIPTION The Pinnacle AltrX Acetabular Cup Liner is part of a modul… | 2005 |
What descends from it? (106)
See all 1068 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073150 | Apex-LNK Poly Acetabular Cup Liners | 2008 | 62 |
| K072963 | Depuy Pinnacle Altrx Acetabular Liners | 2008 | 19 |
| K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | 2010 | 16 |
| K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | 2016 | 6 |
| K102370 | R3 Xlpe Anteverted Liners | 2011 | 6 |
| K172806 | Bencox Mirabo Cup System | 2017 | 4 |
| K103384 | Escalade Acetabular Cup System | 2011 | 3 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | 2024 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K073150 (Omni Life Science, Inc., 2008) has gone furthest, with 62 descendants of its own.
- 9 other devices also cite its predicate K033273.
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 AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from…
Read the full statement (136 words)
The Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The Pinnacle AltrX Acetabular Cup Liners are indicated for use with the Pinnacle Acetabular Cups in cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062148: Depuy Pinnacle Altrx Acetabular Cup Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062148
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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