510(k) Report

510(k) · Cleared

Cleared

Delta Dual Mobility System

K181491510(k) TraditionalCleared May 9, 2019337-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

Lima Corporate S.P.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on May 9, 2019 as substantially equivalent to K150522 (Biomet, Inc., 2015) and 12 other predicates after a 337-day review. Its family tree reaches back 12 generations to 1981.

Decided
May 9, 2019
Review
337 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
13

Its longest line of descent runs back 12 generations to K810258 (1981). 134 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2012: 3 other ancestors2011: 3 other ancestors2007: 7 other ancestors2002: 5 other ancestors2010: 1 other ancestor2009: 4 other ancestors2005: 5 other ancestors2001: 7 other ancestors2000: 10 other ancestors1999: 7 other ancestors1998: 6 other ancestors1997: 3 other ancestors1996: 8 other ancestors1995: 9 other ancestors1994: 15 other ancestors1993: 4 other ancestors1992: 3 other ancestors1985: 4 other ancestors2008: 2 other ancestors2006: 1 other ancestor2004: 4 other ancestors2003: 5 other ancestors1986: 2 other ancestors1991: 2 other ancestors1988: 1 other ancestorK810258 · 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. · 2006K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010×2: 2 generations cleared close together, K101336 (2011), K110555 (2011) K150522 · G7 Dual Mobility System · Biomet, Inc. · 2015 · recalledK161190 · G7 Dual Mobility System, Active Articulation System · Biomet, Inc. · 201619801990200020102020
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 27 other ancestors3 generations back: 18 other ancestors4 generations back: 17 other ancestors5 generations back: 31 other ancestors6 generations back: 12 other ancestors7 generations back: 6 other ancestors8 generations back: 2 other ancestors K161190 · G7 Dual Mobility System, Active Articulation System · Biomet, Inc. · 2016K150522 · G7 Dual Mobility System · Biomet, Inc. · 2015 · recalledK110555 · Arcomxl Active Articulation · Biomet Manufacturing Corp · 2011 · recalledK101336 · E1 Avantage Head · Biomet Manufacturing Corp · 2011 · recalledK100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K061312 · 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 · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 8 generations between
  3. 3 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
  4. 2 generations backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
  5. 1 generation backK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
  6. This deviceK181491 Delta Dual Mobility SystemLima Corporate S.P.A. · 2019
Show all 12 generations
  1. Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 6 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. 5 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  9. 4 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
  10. 3 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
  11. 2 generations backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
  12. 1 generation backK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
  13. This deviceK181491 Delta Dual Mobility SystemLima Corporate S.P.A. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−11K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−10K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−9K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−8K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−7K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−6K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
−5K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010—
−4K101336E1 Avantage HeadBiomet Manufacturing Corp20111
−3K110555Arcomxl Active ArticulationBiomet Manufacturing Corp20112
−2K150522G7 Dual Mobility SystemBiomet, Inc.20151
−1K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.2016—
0 (this device)K181491Delta Dual Mobility SystemLima Corporate S.P.A.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198540
198620
198810
199120
199230
199340
1994150
199590
199680
199730
199860
199970
2000100
200170
200250
200350
200440
200550
200610
200770
200820
200940
201010
201130
201230
201410
FIG. 1 — Lineage of K181491, 1981–2019Source: 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? (13)

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
*K150522G7 Dual Mobility System
Summary page 5
…cementless use. The Delta Dual Mobility System is intended to be used with Delta TT Acetabular System. Predicate Devices: • G7 Dual Mobility System (Zimmer Biomet, K150522, K161190); • MDM X3 (Stryker/Howmedica, K103233, K112556); • Delta-TT acetabular System (Limacorporate, K112898, K141395);…
Biomet, Inc.20151
*K161190G7 Dual Mobility System, Active Articulation System
Summary page 5
…ss use. The Delta Dual Mobility System is intended to be used with Delta TT Acetabular System. Predicate Devices: • G7 Dual Mobility System (Zimmer Biomet, K150522, K161190); • MDM X3 (Stryker/Howmedica, K103233, K112556); • Delta-TT acetabular System (Limacorporate, K112898, K141395); • Pola…
Biomet, Inc.2016—
*K103233Modular Dual Mobility Liner, X3 Acetabular Insert
Summary page 5
…intended to be used with Delta TT Acetabular System. Predicate Devices: • G7 Dual Mobility System (Zimmer Biomet, K150522, K161190); • MDM X3 (Stryker/Howmedica, K103233, K112556); • Delta-TT acetabular System (Limacorporate, K112898, K141395); • Polarcup Dual Mobility System (Smith&Nephew, K…
Howmedica Osteonics Corp.20111
*K112556Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts
Summary page 5
…to be used with Delta TT Acetabular System. Predicate Devices: • G7 Dual Mobility System (Zimmer Biomet, K150522, K161190); • MDM X3 (Stryker/Howmedica, K103233, K112556); • Delta-TT acetabular System (Limacorporate, K112898, K141395); • Polarcup Dual Mobility System (Smith&Nephew, K070278, K…
Howmedica Osteonics Corp.20111
*K112898Delta TT Cups, Delta TT Liners, Bone Screws
Summary page 4
…system. The Delta Dual Mobility System is intended for cementless use in total hip arthroplasty. The system is composed of an acetabular cup shell (previously cleared in K112898, K141395), a fixed liner, a mobile liner and a femoral head (previously cleared in K112158, K141327, K143509). Only femoral heads…
Lima Corporate S.P.A.2012—
*K141395Delta TT Acetabular System
Summary page 4
…he Delta Dual Mobility System is intended for cementless use in total hip arthroplasty. The system is composed of an acetabular cup shell (previously cleared in K112898, K141395), a fixed liner, a mobile liner and a femoral head (previously cleared in K112158, K141327, K143509). Only femoral heads with off…
Lima Corporate S.P.A.20141
*K070278Polarcup Dual Mobility System
Summary page 5
…; • MDM X3 (Stryker/Howmedica, K103233, K112556); • Delta-TT acetabular System (Limacorporate, K112898, K141395); • Polarcup Dual Mobility System (Smith&Nephew, K070278, K110135, K122244). • Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners (Biomet, K023357, K032…
Plus Orthopedics AG2007—
*K110135Polarcup Dual Mobility System
Summary page 5
…M X3 (Stryker/Howmedica, K103233, K112556); • Delta-TT acetabular System (Limacorporate, K112898, K141395); • Polarcup Dual Mobility System (Smith&Nephew, K070278, K110135, K122244). • Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners (Biomet, K023357, K032396, K042…
Smith & Nephew, Inc.2011—
*K122244Polarcup Dual Mobility System
Summary page 5
…yker/Howmedica, K103233, K112556); • Delta-TT acetabular System (Limacorporate, K112898, K141395); • Polarcup Dual Mobility System (Smith&Nephew, K070278, K110135, K122244). • Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners (Biomet, K023357, K032396, K042051, K070…
Smith & Nephew, Inc.2012—
*K023357Arcpm 1050 Resin-Hips
Summary page 5
…Polarcup Dual Mobility System (Smith&Nephew, K070278, K110135, K122244). • Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners (Biomet, K023357, K032396, K042051, K070369). Comparable Features to Predicate Device(s): The intended use and indications of the Delta Dual Mobi…
Biomet Orthopedics, Inc.20021
*K032396Ringloc 36MM Line and Modular Femoral Heads
Summary page 5
…Dual Mobility System (Smith&Nephew, K070278, K110135, K122244). • Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners (Biomet, K023357, K032396, K042051, K070369). Comparable Features to Predicate Device(s): The intended use and indications of the Delta Dual Mobility Syst…
Biomet, Inc.20033
*K042051Arcomxl Polyethylene Liners
Summary page 5
…ility System (Smith&Nephew, K070278, K110135, K122244). • Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners (Biomet, K023357, K032396, K042051, K070369). Comparable Features to Predicate Device(s): The intended use and indications of the Delta Dual Mobility System are th…
Biomet, Inc.20051
*K070369Regenerx Ringloc + Modular Acetabular Shells
Summary page 5
…tem (Smith&Nephew, K070278, K110135, K122244). • Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners (Biomet, K023357, K032396, K042051, K070369). Comparable Features to Predicate Device(s): The intended use and indications of the Delta Dual Mobility System are the same as…
Biomet, Inc.200719

Also cleared against K150522: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 38 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
  • 35 of the 134 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K150522.

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. 2019, 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 Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or

improved hip function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;

• Rheumatoid arthritis;

• Post-traumatic arthritis,

• Correction of functional deformity;

• Fractures, dislocation of the hip and unsuccessful cup arthroplasty.

• Revisions in cases of good remaining bone stock.

Delta TT cup is intended for cementless use.

The Delta Dual Mobility System is intended to be used with Delta TT Acetabular System.

Indications for use as stated in the FDA summary.

Also cleared against K150522

8 other devices cite the same predicate.

  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
  • K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc. · 2021
  • K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG · 20211 recall
  • K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P. · 20212 recalls
  • K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc. · 2018

More from Lima Corporate S.P.A.

64 FDA decisions under this applicant name. See the company

  • K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026
  • K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A. · 2025
  • K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
  • K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
  • K243615Physica Porous Femoral ComponentsLima Corporate S.P.A. · 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/K181491 · printed Nov 5, 2026

Cite this page

510(k) Report. “K181491: Delta Dual Mobility System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181491

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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