510(k) Report

510(k) · Cleared

Cleared

Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper

K101229510(k) TraditionalCleared Dec 3, 2010214-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 Dec 3, 2010 as substantially equivalent to K091508 (Zimmer, Inc., 2009) and 1 other predicate after a 214-day review. Its family tree reaches back 4 generations to 1994. 143 later devices descend from it.

Decided
Dec 3, 2010
Review
214 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K934765 (1994). 8 ancestors in all. 143 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 2 other ancestors2020: 10 descendants cleared2012: 5 descendants cleared2011: 1 descendant cleared2021: 9 descendants cleared2015: 5 descendants cleared2013: 3 descendants cleared2014: 4 descendants cleared2018: 8 descendants cleared2019: 17 descendants cleared2017: 2 descendants cleared2022: 12 descendants cleared2023: 11 descendants cleared2025: 16 descendants cleared2026: 21 descendants cleared2024: 16 descendants cleared2016: 3 descendants clearedK934765 · Trilogy Acetabular System · Zimmer, Inc. · 1994 · recalledK021891 · Zimmer Trabecular Metal Modular Acetabular System · Zimmer, Inc. · 2002 · recalledK091508 · Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System · Zimmer, Inc. · 2009 · recalledK093846 · Longevity IT Highly Crosslinked Polyethylene Elevated Liners · Zimmer, Inc. · 20101990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 18 descendants3 generations forward: 26 descendants4 generations forward: 45 descendants5 generations forward: 33 descendants6 generations forward: 11 descendants7 generations forward: 3 descendants K093846 · Longevity IT Highly Crosslinked Polyethylene Elevated Liners · Zimmer, Inc. · 2010K091508 · Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System · Zimmer, Inc. · 2009 · recalledK021891 · Zimmer Trabecular Metal Modular Acetabular System · Zimmer, Inc. · 2002 · recalledK934765 · Trilogy Acetabular System · Zimmer, Inc. · 1994 · recalled0+5
  1. Root · 4 generations backK934765 Trilogy Acetabular SystemZimmer, Inc. · 1994 · Recalled
  2. 3 generations backK021891 Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002 · Recalled
  3. 2 generations backK091508 Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular…Zimmer, Inc. · 2009 · Recalled
  4. 1 generation backK093846 Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010
  5. This deviceK101229 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 · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
  8. Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
  9. Descendant · 2 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
  10. Descendant · 3 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014

Showing 5 of 143 descendants. See all descendants

Descendants cleared per year

2011: 12012: 52013: 32014: 42015: 52016: 32017: 22018: 82019: 172020: 102021: 92022: 122023: 112024: 162025: 162026: 21
2011high 21 (2026) · low 1 (2011)2026

Most influential descendants

Showing 5 of 143 · 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
−4K934765Trilogy Acetabular SystemZimmer, Inc.199416
−3K021891Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc.20023
−2K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemZimmer, Inc.20093
−1K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc.2010—
0 (this device)K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum…Zimmer, Inc.2010—
+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
200020
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201250
201330
201440
201550
201630
201720
201880
2019170
2020100
202190
2022120
2023110
2024160
2025160
2026210
FIG. 1 — Lineage of K101229, 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 24.2 · 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? (2)

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
*K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System
Summary page 1
…h and Trilogy Integrated Taper (IT) Acetabular Systems, mianufactured by Zimmer Inc., K091508, cleared September 11, 2009. Longevity IT Highly Crosslinked Polyethylene…
Zimmer, Inc.20093
*K093846Longevity IT Highly Crosslinked Polyethylene Elevated Liners
Summary page 1
…evity IT Highly Crosslinked Polyethylene Elevated Liners manufactured by Zimmer Inc., K093846, cleared 04 February 2010. -% 326…
Zimmer, Inc.2010—

Also cleared against K091508: 17 other devices →

What descends from it? (143)

See all 143

7 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
K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137
K151448Continuum and Trilogy Integrated Taper (IT) Acetabular SystemsZimmer, Inc.20156
K203420EcoFit® Hip SystemImplantcast GmbH20214
K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.20201
K123019Longevity IT Highly Crosslinked Polyethyene LinersZimmer, Inc.20120

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 16 years and passes through 1 company; a new generation was cleared every 7.0 years on median.
  • 3 of the 8 ancestors have a recall of any class.
  • Of its descendants, K103662 (Zimmer, Inc., 2011) has gone furthest, with 137 descendants of its own.
  • 17 other devices also cite its predicate K091508.

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. 2010, 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 system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthiitis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fuised hip, fracture of the pelvis, and diastrophic variant.

The system is intended for use either wit or without bone cement in total hip arthroplasty.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K101229: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101229

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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