510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Trinity™ Dual Mobility System

K170359510(k) TraditionalCleared Oct 31, 2017267-day reviewClass II21 CFR 888.3353Recalls 1

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

Corin U.S.A. Limited · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Oct 31, 2017 as substantially equivalent to K103233 (Howmedica Osteonics Corp., 2011) and 4 other predicates after a 267-day review. Its family tree reaches back 13 generations to 1981. 10 later devices descend from it. It has been recalled once.

Decided
Oct 31, 2017
Review
267 days
Class
Class II
Product code
LZO
Recalls
1
Predicates
5

Its longest line of descent runs back 13 generations to K810258 (1981). 139 ancestors in all. 10 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2012: 1 other ancestor2011: 3 other ancestors2010: 2 other ancestors2009: 5 other ancestors2007: 5 other ancestors2004: 8 other ancestors2001: 8 other ancestors2000: 14 other ancestors1999: 6 other ancestors2006: 2 other ancestors2005: 4 other ancestors2003: 5 other ancestors2002: 9 other ancestors1997: 7 other ancestors1994: 11 other ancestors2008: 1 other ancestor1998: 4 other ancestors1996: 7 other ancestors1995: 8 other ancestors1985: 2 other ancestors1993: 2 other ancestors1992: 3 other ancestors1991: 3 other ancestors1988: 1 other ancestor1990: 1 other ancestor1984: 1 other ancestor1987: 1 other ancestor2021: 2 descendants cleared2019: 2 descendants cleared2020: 1 descendant cleared2026: 2 descendants cleared2022: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010×2: 2 generations cleared close together, K103120 (2011), K110087 (2011) ×2: 2 generations cleared close together, K130343 (2013), K131647 (2013) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 14 other ancestors3 generations back: 24 other ancestors4 generations back: 29 other ancestors5 generations back: 27 other ancestors6 generations back: 17 other ancestors7 generations back: 8 other ancestors8 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K131647 · Trinity Acetabular System · Corin USA · 2013K130343 · Corin Trinity Acetabular System with Extra-Long Heads · Corin USA · 2013 · recalledK110087 · Corin Trinity Acetbular System with Hxlpe Liners · Corin USA · 2011K103120 · Corin Biolox Delta Femoral Heads · Corin USA · 2011K100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations between
  3. 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  4. 2 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
  5. 1 generation backK131647 Trinity Acetabular SystemCorin USA · 2013
  6. This deviceK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017
  7. Descendant · cites it directly · 3 of its ownK191831 MobiliT CupCorin U.S.A. Limited · 2020
  8. Descendant · cites it directly · 3 of its ownK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
  9. Descendant · cites it directly · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
  10. Descendant · 2 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
  11. Descendant · 2 generations on · 1 of its ownK200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and…Waldemar Link GmbH & Co. KG · 2021 · Recalled
Show all 13 generations
  1. Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 7 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. 6 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. 5 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  10. 4 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
  11. 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  12. 2 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
  13. 1 generation backK131647 Trinity Acetabular SystemCorin USA · 2013
  14. This deviceK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2019: 22020: 12021: 22022: 12023: 12024: 12026: 2
2019high 2 (2019) · low 0 (2025)2026

Most influential descendants

Showing 5 of 10 · See all
  • K191831MobiliT CupCorin U.S.A. Limited · 2020 · cites it directly3descendants
  • K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · cites it directly3descendants
  • K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · cites it directly2descendants
  • K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 2 generations on1descendant
  • K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG · 2021 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−12K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−11K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−10K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−9K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−8K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−7K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
−6K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
−5K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
−4K103120Corin Biolox Delta Femoral HeadsCorin USA2011—
−3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
−2K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA20132
−1K131647Trinity Acetabular SystemCorin USA2013—
0 (this device)K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017—
+1K191831MobiliT CupCorin U.S.A. Limited2020—
+1K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG20191
+1K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular…Corin, Ltd.2021—
+2K241472Icona Hip StemCorin U.S.A. Limited2024—
+2K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and…Waldemar Link GmbH & Co. KG20211

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198520
198710
198810
199010
199130
199230
199320
1994110
199580
199670
199770
199840
199960
2000140
200180
200290
200350
200480
200540
200620
200750
200810
200950
201020
201130
201210
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
202010
202120
202210
202310
202410
202620
FIG. 1 — Lineage of K170359, 1981–2026Source: 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? (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
*K103233Modular Dual Mobility Liner, X3 Acetabular Insert
Summary page 4
…Nonporous uncemented prosthesis 8. Legally Marketed Devices to which Substantial Equivalence is claimed: • Stryker MDM™ (K103233) • Zimmer Biomet G7 Dual Mobility System (K150522) • Corin Trinity Acetabular System (K110087, K111481, K131647)…
Howmedica Osteonics Corp.20111
*K150522G7 Dual Mobility System
Summary page 4
…d prosthesis 8. Legally Marketed Devices to which Substantial Equivalence is claimed: • Stryker MDM™ (K103233) • Zimmer Biomet G7 Dual Mobility System (K150522) • Corin Trinity Acetabular System (K110087, K111481, K131647) 9. Device Description: The TrinityTM Dual Mobility Syst…
Biomet, Inc.20151
*K110087Corin Trinity Acetbular System with Hxlpe Liners
Summary page 4
…ch Substantial Equivalence is claimed: • Stryker MDM™ (K103233) • Zimmer Biomet G7 Dual Mobility System (K150522) • Corin Trinity Acetabular System (K110087, K111481, K131647) 9. Device Description: The TrinityTM Dual Mobility System is a modular acetabular system consisting of two…
Corin USA2011—
*K111481Corin Trinity Acetabular System Ecima Liners
Summary page 4
…ntial Equivalence is claimed: • Stryker MDM™ (K103233) • Zimmer Biomet G7 Dual Mobility System (K150522) • Corin Trinity Acetabular System (K110087, K111481, K131647) 9. Device Description: The TrinityTM Dual Mobility System is a modular acetabular system consisting of two articula…
Corin USA20121
*K131647Trinity Acetabular System
Summary page 4
…ivalence is claimed: • Stryker MDM™ (K103233) • Zimmer Biomet G7 Dual Mobility System (K150522) • Corin Trinity Acetabular System (K110087, K111481, K131647) 9. Device Description: The TrinityTM Dual Mobility System is a modular acetabular system consisting of two articulating surf…
Corin USA2013—

Also cleared against K103233: 10 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K191831MobiliT CupCorin U.S.A. Limited20203
K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG20193
K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212
K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260
K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 28, 2021Class IIZ-2608-2021StorageThe packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 36 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
  • 39 of the 138 ancestors have a recall of any class.
  • Of its descendants, K191831 (Corin U.S.A. Limited, 2020) has gone furthest, with 3 descendants of its own.
  • 10 other devices also cite its predicate K103233.

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. 2017, 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 Trinity™ Dual Mobility System is intended for use in the following indications:

1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis

2. Rheumatoid Arthritis

3. Correction of functional deformity

4. Revision of previously failed total hip arthroplasty,

5. Patients at increased risk of dislocation

6. Developmental dysplasia of the hip (DDH)

The TrinityTM Dual Mobility System is indicated for cementless use only.

Indications for use as stated in the FDA summary.

Also cleared against K103233

10 other devices cite the same predicate.

  • K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
  • K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2023
  • K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG · 20211 recall
  • K200854DePuy PINNACLE Dual Mobility LinerDepuy Ireland UC · 2020
  • K181491Delta Dual Mobility SystemLima Corporate S.P.A. · 2019
  • K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019

More from Corin U.S.A. Limited

21 FDA decisions under this applicant name. See the company

  • K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025
  • K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited · 2025
  • K241472Icona Hip StemCorin U.S.A. Limited · 2024
  • K241570Unity Total Knee SystemCorin U.S.A. Limited · 2024
  • K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited · 2024

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/K170359 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170359: Trinity™ Dual Mobility System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170359

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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