510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System

K091508510(k) TraditionalCleared Sep 11, 2009112-day reviewClass II21 CFR 888.3358Recalls 3

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 Sep 11, 2009 as substantially equivalent to K021891 (Zimmer, Inc., 2002) and 4 other predicates after a 112-day review. Its family tree reaches back 2 generations to 1994. 246 later devices descend from it. It has been recalled 3 times.

Decided
Sep 11, 2009
Review
112 days
Class
Class II
Product code
LPH
Recalls
3
Predicates
5

Its longest line of descent runs back 2 generations to K934765 (1994). 6 ancestors in all. 246 later devices descend from it, 18 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 2 other ancestors2010: 3 descendants cleared2020: 20 descendants cleared2012: 11 descendants cleared2011: 3 descendants cleared2018: 17 descendants cleared2015: 8 descendants cleared2022: 18 descendants cleared2014: 6 descendants cleared2017: 8 descendants cleared2013: 13 descendants cleared2021: 13 descendants cleared2016: 9 descendants cleared2019: 25 descendants cleared2025: 26 descendants cleared2026: 27 descendants cleared2023: 18 descendants cleared2024: 21 descendants clearedK934765 · Trilogy Acetabular System · Zimmer, Inc. · 1994 · recalledK021891 · Zimmer Trabecular Metal Modular Acetabular System · Zimmer, Inc. · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 18 descendants2 generations forward: 49 descendants3 generations forward: 52 descendants4 generations forward: 48 descendants5 generations forward: 37 descendants6 generations forward: 28 descendants7 generations forward: 8 descendants8 generations forward: 3 descendants9 generations forward: 3 descendants K021891 · Zimmer Trabecular Metal Modular Acetabular System · Zimmer, Inc. · 2002 · recalledK934765 · Trilogy Acetabular System · Zimmer, Inc. · 1994 · recalled0+5
  1. Root · 2 generations backK934765 Trilogy Acetabular SystemZimmer, Inc. · 1994 · Recalled
  2. 1 generation backK021891 Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002 · Recalled
  3. This deviceK091508 Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular…Zimmer, Inc. · 2009
  4. Descendant · cites it directly · 144 of its ownK093846 Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010
  5. Descendant · cites it directly · 143 of its ownK101229 Longevity IT Highly Crosslinked Polyethylene Elevated Liners…Zimmer, Inc. · 2010
  6. Descendant · cites it directly · 137 of its ownK103662 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems…Zimmer, Inc. · 2011
  7. Descendant · cites it directly · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  8. Descendant · cites it directly · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012

Showing 5 of 246 descendants. See all descendants

Descendants cleared per year

2010: 32011: 32012: 112013: 132014: 62015: 82016: 92017: 82018: 172019: 252020: 202021: 132022: 182023: 182024: 212025: 262026: 27
2010high 27 (2026) · low 3 (2010)2026

Most influential descendants

Showing 5 of 246 · See all
  • K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010 · cites it directly144descendants
  • K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Zimmer, Inc. · 2010 · cites it directly143descendants
  • K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc. · 2011 · cites it directly137descendants
  • K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · cites it directly109descendants
  • K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · cites it directly88descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K934765Trilogy Acetabular SystemZimmer, Inc.199416
−1K021891Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc.20023
0 (this device)K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemZimmer, Inc.2009—
+1K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc.2010—
+1K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum…Zimmer, Inc.2010—
+1K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT…Zimmer, Inc.2011—
+1K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
+1K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201130
2012110
2013130
201460
201580
201690
201780
2018170
2019250
2020200
2021130
2022180
2023180
2024210
2025260
2026270
FIG. 1 — Lineage of K091508, 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? (5)

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
*K021891Zimmer Trabecular Metal Modular Acetabular System
Summary page 1
…uncemented; 21 CFR 888.3353 Predicate Device: TrabecularMetal Acetabular System, manufactured by Zimmer, Inc. (K021891), Trilogy Acetabular System, manufactured by Zimmer, Inc. (K934765),…
Zimmer, Inc.20023
*K934765Trilogy Acetabular System
Summary page 1
…manufactured by Zimmer, Inc. (K021891), Trilogy Acetabular System, manufactured by Zimmer, Inc. (K934765), Converge Acetabular System, manufactured by Zimmer, Inc…
Zimmer, Inc.199416
*K012739Converge Acetabular SystemSulzer Orthopedics, Inc.2001—
*K002960Trilogy Acetabular System Large Head Liner, Model 6353
Summary page 1
…immer, Inc. (KO 12739), Trilogy Acetabular System Large Head Liner, manufactured by Zimmer, Inc. (K002960), and Trilogy Acetabular System 46mm Large Head Liners, manufactured by…
Zimmer, Inc.2000—
*K003478Triology Acetabular System 46MM Large Head Liners, Model 6310
Summary page 1
…c. (K002960), and Trilogy Acetabular System 46mm Large Head Liners, manufactured by Zimmer, Inc. (K003478) 14 Page2 May 21, 200…
Zimmer, Inc.2001—

Also cleared against K021891: 3 other devices →

What descends from it? (246)

See all 246

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

NumberDeviceApplicantDecidedDescendants
K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc.2010144
K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Zimmer, Inc.2010143
K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc.2011137
K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109
K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288
K121874G7 Acetabular SystemBiomet Manufacturing Corp201253
K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212
K141395Delta TT Acetabular SystemLima Corporate S.P.A.201410
K163577Ecofit® Hip SystemImplantcast GmbH20179
K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 1, 2014Class IIZ-0094-2015Equipment maintenanceThe affected products are missing polar boss threads.
Mar 19, 2010Not classifiedZ-0072-2011Device DesignThe firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.
Mar 19, 2010Not classifiedZ-0071-2011Device DesignThe firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 8.4 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K093846 (Zimmer, Inc., 2010) has gone furthest, with 144 descendants of its own.
  • 3 other devices also cite its predicate K021891.

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. 2009, this device’s year, is highlighted.

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 Continuum and Trilogy IT Acetabular Systems are indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The devices are intended for use either with or without bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K021891

3 other devices cite the same predicate.

  • K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
  • K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
  • K093561Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2010

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/K091508 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091508

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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