510(k) Report

510(k) · Cleared

Cleared

Longevity IT Highly Crosslinked Polyethylene Elevated Liners

K093846510(k) SpecialCleared Feb 4, 201051-day reviewClass II21 CFR 888.3353

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

Zimmer, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Feb 4, 2010 as substantially equivalent to K091508 (Zimmer, Inc., 2009) after a 51-day review. Its family tree reaches back 3 generations to 1994. 144 later devices descend from it.

Decided
Feb 4, 2010
Review
51 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K934765 (1994). 7 ancestors in all. 144 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 2 other ancestors2010: 1 descendant cleared2020: 10 descendants cleared2012: 5 descendants cleared2015: 5 descendants cleared2013: 3 descendants cleared2011: 1 descendant cleared2021: 9 descendants cleared2014: 4 descendants cleared2018: 8 descendants cleared2019: 17 descendants cleared2017: 2 descendants cleared2022: 12 descendants cleared2023: 11 descendants cleared2025: 16 descendants cleared2016: 3 descendants cleared2026: 21 descendants cleared2024: 16 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 15 descendants3 generations forward: 22 descendants4 generations forward: 36 descendants5 generations forward: 42 descendants6 generations forward: 19 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K091508 · 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 · 3 generations backK934765 Trilogy Acetabular SystemZimmer, Inc. · 1994 · Recalled
  2. 2 generations backK021891 Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002 · Recalled
  3. 1 generation backK091508 Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular…Zimmer, Inc. · 2009 · Recalled
  4. This deviceK093846 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 · 2 generations on · 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 · 3 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled

Showing 5 of 144 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 52013: 32014: 42015: 52016: 32017: 22018: 82019: 172020: 102021: 92022: 122023: 112024: 162025: 162026: 21
2010high 21 (2026) · low 1 (2010)2026

Most influential descendants

Showing 5 of 144 · See all
  • 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 · 2 generations on137descendants
  • 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 · 3 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K934765Trilogy Acetabular SystemZimmer, Inc.199416
−2K021891Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc.20023
−1K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemZimmer, Inc.20093
0 (this device)K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc.2010—
+1K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum…Zimmer, Inc.2010—
+2K103662Continuum 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
+3K121874G7 Acetabular SystemBiomet Manufacturing Corp20123

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201250
201330
201440
201550
201630
201720
201880
2019170
2020100
202190
2022120
2023110
2024160
2025160
2026210
FIG. 1 — Lineage of K093846, 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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (1)

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
…ContinUUMTm and Trilogy®Integrated Taper (IT) Acetahular Systems, manufactured by Zimmer Inc., K091508, cleared September 11, 2009. Page 2 December 14, 2009 Device Description: The Longevity IT Highly…
Zimmer, Inc.20093

Also cleared against K091508: 17 other devices →

What descends from it? (144)

See all 144

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

NumberDeviceApplicantDecidedDescendants
K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Zimmer, Inc.2010143
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
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 7 ancestors have a recall of any class.
  • Of its descendants, K101229 (Zimmer, Inc., 2010) has gone furthest, with 143 descendants of its own.
  • 17 other devices also cite its predicate K091508.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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 · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

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 osteoarthritis, avascular necrosis, pro rso acetabuli,

traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic

variant.

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

Indications for use as stated in the FDA summary.

Also cleared against K091508

17 other devices cite the same predicate.

  • K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd. · 2022
  • K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 20201 recall
  • K173380b-ONE® Total Hip SystemB-One Ortho, Corp. · 2018
  • K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
  • K172456Bone Screws 6.5mmLima Corporate S.P.A. · 20182 recalls
  • K163577Ecofit® Hip SystemImplantcast GmbH · 20171 recall

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 LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K093846 · printed Nov 5, 2026

Cite this page

510(k) Report. “K093846: Longevity IT Highly Crosslinked Polyethylene Elevated Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093846

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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