510(k) Report

510(k) · Cleared

Cleared

Trilogy Acetabular System Longevity Crosslinked Polyethylene

K990135510(k) TraditionalCleared Jul 12, 1999180-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

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

Cleared on Jul 12, 1999 as substantially equivalent to K934765 (Zimmer, Inc., 1994) and 2 other predicates after a 180-day review. Its family tree reaches back 1 generation to 1994. 192 later devices descend from it.

Decided
Jul 12, 1999
Review
180 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K934765 (1994). 3 ancestors in all. 192 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 1 other ancestor2012: 13 descendants cleared2011: 6 descendants cleared2010: 3 descendants cleared2019: 19 descendants cleared2015: 8 descendants cleared2025: 20 descendants cleared2013: 7 descendants cleared2020: 11 descendants cleared2014: 5 descendants cleared2018: 10 descendants cleared2026: 24 descendants cleared2021: 11 descendants cleared2023: 12 descendants cleared2022: 15 descendants cleared2017: 5 descendants cleared2016: 4 descendants cleared2024: 19 descendants clearedK934765 · Trilogy Acetabular System · Zimmer, Inc. · 1994 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 26 descendants3 generations forward: 51 descendants4 generations forward: 47 descendants5 generations forward: 38 descendants6 generations forward: 19 descendants7 generations forward: 6 descendants K934765 · Trilogy Acetabular System · Zimmer, Inc. · 1994 · recalled0+5
  1. Root · 1 generation backK934765 Trilogy Acetabular SystemZimmer, Inc. · 1994 · Recalled
  2. This deviceK990135 Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc. · 1999
  3. Descendant · cites it directly · 137 of its ownK103662 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems…Zimmer, Inc. · 2011
  4. Descendant · cites it directly · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
  5. Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
  6. Descendant · 2 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
  7. Descendant · 3 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014

Showing 5 of 192 descendants. See all descendants

Descendants cleared per year

2010: 32011: 62012: 132013: 72014: 52015: 82016: 42017: 52018: 102019: 192020: 112021: 112022: 152023: 122024: 192025: 202026: 24
2010high 24 (2026) · low 3 (2010)2026

Most influential descendants

Showing 5 of 192 · See all
  • K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc. · 2011 · cites it directly137descendants
  • K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · cites it directly88descendants
  • K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 2 generations on59descendants
  • K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 2 generations on53descendants
  • K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 3 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934765Trilogy Acetabular SystemZimmer, Inc.199416
0 (this device)K990135Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc.1999—
+1K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT…Zimmer, Inc.2011—
+1K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.2012—
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.20122
+2K121874G7 Acetabular SystemBiomet Manufacturing Corp20123
+3K140669G7 Osseoti Acetublar ShellsBiomet, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201160
2012130
201370
201450
201580
201640
201750
2018100
2019190
2020110
2021110
2022150
2023120
2024190
2025200
2026240
FIG. 1 — Lineage of K990135, 1994–2026Source: 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 24.3 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K934765Trilogy Acetabular System
Summary page 1
…p Prosthesis Classification Name: Hip Joint Metal/Polymer/Metal Semiconstrained Porous-Coated Uncemented Prosthesis Predicate Devices: - Trilogy® Acetabular System, K934765, cleared April 29, 1994 Summary of Safety and Effectiveness (Continued) - Trilogy® Acetabular System, 36 mm Line…
Zimmer, Inc.199416
*K953490Trilogy Acetabular Shell & Liners 36MM
Summary page 2
…Trilogy® Acetabular System, K934765, cleared April 29, 1994 Summary of Safety and Effectiveness (Continued) - Trilogy® Acetabular System, 36 mm Liners, K953490, cleared October 20, 1995 - Trilogy® Acetabular System, 7 mm Offset Liners, K954698, cleared January 17, 1996 Device Descriptio…
Zimmer, Inc.19952
*K954698Trilogy Acetabular Component 7MM Offset
Summary page 2
…of Safety and Effectiveness (Continued) - Trilogy® Acetabular System, 36 mm Liners, K953490, cleared October 20, 1995 - Trilogy® Acetabular System, 7 mm Offset Liners, K954698, cleared January 17, 1996 Device Description The Trilogy Acetabular System Longevity Crosslinked Polyethylene Liners are modula…
Zimmer, Inc.19961

Also cleared against K934765: 11 other devices →

What descends from it? (192)

See all 192

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

NumberDeviceApplicantDecidedDescendants
K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc.2011137
K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288
K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035
K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023
K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194

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?

  • 3 of the 3 ancestors have a recall of any class.
  • Of its descendants, K103662 (Zimmer, Inc., 2011) has gone furthest, with 137 descendants of its own.
  • 11 other devices also cite its predicate K934765.

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 Trilogy® Acetabular System is indicated for either cemented or noncemented use in skeletally mature individuals undergoing surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K934765

11 other devices cite the same predicate.

  • K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
  • K213842ONVOY Acetabular SystemGlobus Medical, Inc. · 2022
  • K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
  • K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
  • K101472Multifit Total Hip SystemOtis Biotech Co., Ltd. · 2011
  • K092443Interface Acetabular Cup LinersOmni Life Science, Inc. · 2009

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, 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/K990135 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990135: Trilogy Acetabular System Longevity Crosslinked Polyethylene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990135

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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