510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Trilogy Acetabular Component 7MM Offset

K954698510(k) TraditionalCleared Jan 17, 199697-day reviewClass II21 CFR 888.3358Recalls 1

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 Jan 17, 1996 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 195 later devices descend from it. It has been recalled once.

Decided
Jan 17, 1996
Review
97 days
Class
Class II
Product code
LPH
Recalls
1
Predicates
0

195 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1999: 1 descendant cleared1998: 1 descendant cleared2012: 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 cleared1995200020052010201520202025
  1. This deviceK954698 Trilogy Acetabular Component 7MM OffsetZimmer, Inc. · 1996
  2. Descendant · cites it directly · 192 of its ownK990135 Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc. · 1999
  3. Descendant · 2 generations on · 137 of its ownK103662 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems…Zimmer, Inc. · 2011
  4. Descendant · 2 generations on · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
  5. Descendant · 3 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
  6. Descendant · 3 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled

Showing 5 of 195 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 12010: 32011: 62012: 132013: 72014: 52015: 82016: 42017: 52018: 102019: 192020: 112021: 112022: 152023: 122024: 192025: 202026: 24
1997high 24 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 195 · See all
  • K990135Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc. · 1999 · cites it directly192descendants
  • K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc. · 2011 · 2 generations on137descendants
  • K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · 2 generations on88descendants
  • K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 3 generations on59descendants
  • K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 3 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954698Trilogy Acetabular Component 7MM OffsetZimmer, Inc.1996—
+1K990135Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc.1999—
+2K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT…Zimmer, Inc.2011—
+2K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.2012—
+3K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.20122
+3K121874G7 Acetabular SystemBiomet Manufacturing Corp20123

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
201030
201160
2012130
201370
201450
201580
201640
201750
2018100
2019190
2020110
2021110
2022150
2023120
2024190
2025200
2026240
FIG. 1 — Lineage of K954698, 1996–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (195)

See all 195

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

NumberDeviceApplicantDecidedDescendants
K990135Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc.1999192
K973163Acetabular Shells with Mesh Ingrowth SurfaceHowmedica Corp.19971

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 11, 2013Class IIZ-1024-2014PackagingZimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K990135 (Zimmer, Inc., 1999) has gone furthest, with 192 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—

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/K954698 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954698: Trilogy Acetabular Component 7MM Offset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954698

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026