510(k) · Cleared
ClearedVivacit-E Vitamin E Highly Crosslinked Polyethylene Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Jun 4, 2012 as substantially equivalent to K091508 (Zimmer, Inc., 2009) and 5 other predicates after a 119-day review. Its family tree reaches back 8 generations to 1981. 88 later devices descend from it.
- Decided
- Jun 4, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K810258 (1981). 47 ancestors in all. 88 later devices descend from it, 7 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 4 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 3 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 2 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 1 generation backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- This deviceK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- Descendant · cites it directly · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 17 of its ownK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
- Descendant · 2 generations on · 15 of its ownK172524 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018
- Descendant · 2 generations on · 15 of its ownK141635 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- Descendant · cites it directly · 15 of its ownK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · cites it directly59descendants
- K150090Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015 · 2 generations on17descendants
- K172524Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018 · 2 generations on15descendants
- K141635Arthrex Ibalance Tka SystemArthrex, Inc. · 2014 · 2 generations on15descendants
- K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −4 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −3 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −2 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −1 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| 0 (this device) | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| +1 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +2 | K150090 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2015 | — |
| +2 | K172524 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2018 | — |
| +2 | K141635 | Arthrex Ibalance Tka System | Arthrex, Inc. | 2014 | — |
| +1 | K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular Surface | Zimmer, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 6 | 0 |
| 2024 | 13 | 0 |
| 2025 | 12 | 0 |
| 2026 | 12 | 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 OQG? 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 OQG device
- #1 K200328 Tesera Trabecular Technologies (T3) Acetabular…score 4.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemSummary page 2…30, 2012 Predicate Device: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer, Inc. (K09 1508) Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimme… | 2009 |
| * | K093846 | Longevity IT Highly Crosslinked Polyethylene Elevated LinersSummary page 2…(K09 1508) Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, Inc. (K093 846) Continuum and Trilogy Integrated Taper (IT) Acetabular Systems and Longevity IT Hig… | 2010 |
| * | K101229 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular… | 2010 |
| * | K103662 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Summary page 2…Acetabular Systems and Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, Inc. (K103662) Trilogy Acetabular System Longevity Crosslinked Polyethylene Liners manufactured by… | 2011 |
| * | K990135 | Trilogy Acetabular System Longevity Crosslinked PolyethyleneSummary page 2…662) Trilogy Acetabular System Longevity Crosslinked Polyethylene Liners manufactured by Zimmer, Inc. (K990 135) El Antioxidant Infused Technology, manufactured by Biomet Manufacturing Corp. (K 10… | 1999 |
| * | K100048 | E1 Antioxidant Infused TechnologySummary page 2…Zimmer, Inc. (K990 135) El Antioxidant Infused Technology, manufactured by Biomet Manufacturing Corp. (K 100048) Device Description: The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are neutral and elev… | 2010 |
What descends from it? (88)
See all 887 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121771 | Zimmer Persona the Personalized Knee System | 2012 | 59 |
| K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular Surface | 2012 | 15 |
| K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System… | 2019 | 4 |
| K140701 | Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug | 2014 | 2 |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | 2020 | 1 |
| K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings | 2019 | 1 |
| K173380 | b-ONE® Total Hip System | 2018 | 0 |
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 31 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 15 of the 47 ancestors have a recall of any class.
- Of its descendants, K121771 (Zimmer, Inc., 2012) has gone furthest, with 59 descendants of its own.
- 17 other devices also cite its predicate K091508.
How does its category compare?
All OQG devicesOQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OQG
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OQG
99in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQG
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQG
16in 2025
MAUDE reports naming product code OQG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 144 | 0 | 0 |
| 2013 | 3 | 280 | 1 | 5 |
| 2014 | 3 | 99 | 0 | 31 |
| 2015 | 1 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 3 | 99 | 0 | 27 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 104 |
| 2020 | 2 | — | 0 | 178 |
| 2021 | 2 | — | 0 | 88 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
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, protruslo 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.
https://510kreport.com/device/K120370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120370
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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