510(k) · Cleared
Recalled · Class II · 2025Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Dec 6, 2019 as substantially equivalent to K161190 (Biomet, Inc., 2016) and 2 other predicates after a 267-day review. Its family tree reaches back 12 generations to 1981. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Dec 6, 2019
- Review
- 267 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 12 generations to K810258 (1981). 76 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- 2 generations backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- 1 generation backK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
- This deviceK190656 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 5 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 4 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- 3 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- 2 generations backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- 1 generation backK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
- This deviceK190656 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −5 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −4 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
| −3 | K110555 | Arcomxl Active Articulation | Biomet Manufacturing Corp | 2011 | 2 |
| −2 | K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 | 1 |
| −1 | K161190 | G7 Dual Mobility System, Active Articulation System | Biomet, Inc. | 2016 | — |
| 0 (this device) | K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings | Zimmer, Inc. | 2019 | — |
| +1 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161190 | G7 Dual Mobility System, Active Articulation SystemSummary page 5…K190656 Page 1 of 4 Predicate Device(s): Primary Predicates K161190 G7 Dual Mobility Biomet Inc. System, Active… | 2016 |
| * | K151448 | Continuum and Trilogy Integrated Taper (IT) Acetabular SystemsSummary page 5…System, Active Articulation System Secondary Predicates K151448 Continuum And Trilogy Zimmer Inc. Integrated Taper (IT)… | 2015 |
| * | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersSummary page 5…nd Trilogy Zimmer Inc. Integrated Taper (IT) Acetabular Systems K120370 Continuum-Trilogy IT Zimmer Inc. Acetabular System:… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2025 | Class II | Z-0419-2026 | Labeling mix-ups | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and… |
| Sep 26, 2025 | Class II | Z-0418-2026 | Labeling mix-ups | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and… |
| Aug 14, 2020 | Class II | Z-0057-2021 | Under Investigation by firm | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. |
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.
- 22 of the 76 ancestors have a recall of any class.
- Of its descendants, K253948 (United Orthopedic Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K161190.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• Revision procedures where other treatment or devices have failed.
• Dislocation risks.
Dual Mobility Hip Bearings are single-use implants, intended for uncemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190656 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190656: Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190656
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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