510(k) Report

510(k) · Cleared

Cleared

Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads

K033273510(k) TraditionalCleared May 6, 2004209-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on May 6, 2004 after a 209-day review. The FDA summary names its predicate without a number. 210 later devices descend from it.

Decided
May 6, 2004
Review
209 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

210 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2011: 6 descendants cleared2008: 3 descendants cleared2007: 2 descendants cleared2015: 7 descendants cleared2024: 15 descendants cleared2017: 10 descendants cleared2019: 13 descendants cleared2022: 17 descendants cleared2013: 14 descendants cleared2016: 13 descendants cleared2010: 7 descendants cleared2009: 1 descendant cleared2021: 11 descendants cleared2018: 13 descendants cleared2012: 9 descendants cleared2025: 20 descendants cleared2026: 14 descendants cleared2014: 7 descendants cleared2020: 10 descendants cleared2023: 16 descendants cleared200020052010201520202025
  1. This deviceK033273 Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene…DePuy Orthopaedics, Inc. · 2004
  2. Descendant · cites it directly · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  3. Descendant · cites it directly · 106 of its ownK062148 Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc. · 2006
  4. Descendant · cites it directly · 63 of its ownK062489 Apex Hcla Acetabular Cup LinersOmnilife Science · 2007
  5. Descendant · 2 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
  6. Descendant · cites it directly · 62 of its ownK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008

Showing 5 of 210 descendants. See all descendants

Descendants cleared per year

2006: 22007: 22008: 32009: 12010: 72011: 62012: 92013: 142014: 72015: 72016: 132017: 102018: 132019: 132020: 102021: 112022: 172023: 162024: 152025: 202026: 14
2006high 20 (2025) · low 1 (2009)2026

Most influential descendants

Showing 5 of 210 · See all
  • K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · cites it directly109descendants
  • K062148Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc. · 2006 · cites it directly106descendants
  • K062489Apex Hcla Acetabular Cup LinersOmnilife Science · 2007 · cites it directly63descendants
  • K111911Corin Optimom Modular HeadCorin USA · 2011 · 2 generations on62descendants
  • K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008 · cites it directly62descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033273Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and…DePuy Orthopaedics, Inc.2004—
+1K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
+1K062148Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc.2006—
+1K062489Apex Hcla Acetabular Cup LinersOmnilife Science2007—
+2K111911Corin Optimom Modular HeadCorin USA2011—
+1K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200720
200830
200910
201070
201160
201290
2013140
201470
201570
2016130
2017100
2018130
2019130
2020100
2021110
2022170
2023160
2024150
2025200
2026140
FIG. 1 — Lineage of K033273, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—DePuy Pinnacle Acetabular Cup System Marathon Cross-Linked Polyethylene Liners
Named without a submission number
—
*—Biomet Tri-polar System
Named without a submission number
—
*—DePuy Ultima Unipolar Femoral Heads
Named without a submission number
—
*—DePuy Self-Centering Hip Prosthesis
Named without a submission number
—

What descends from it? (210)

See all 210

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109
K062148Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc.2006106
K062489Apex Hcla Acetabular Cup LinersOmnilife Science200763
K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.200862
K060031Depuy Modular M HeadsDePuy Orthopaedics, Inc.200618
K221636EMPHASYS Acetabular SystemDepuy Ireland UC20227
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245
K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151
K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190
K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170

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?

  • Of its descendants, K110087 (Corin USA, 2011) has gone furthest, with 109 descendants of its own.

How does its category compare?

All LPH devices

LPH 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

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

The Pinnacle ® Enhanced Stability Liner (ESL) is 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 (135 words)

The Pinnacle ® Enhanced Stability Liner (ESL) is 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 ® ESL is indicated for use with the Pinnaclea' Acetabular Cup in cementless application.

Indications for use as stated in the FDA summary.

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K033273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033273: Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033273

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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