# K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jun 4, 2012 after 119 days
- Product code: OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K810258 (1981). 47 ancestors in all.
88 later devices descend from it; 7 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009) Summary page 2.
- K093846: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Zimmer, Inc. (2010) Summary page 2.
- K101229: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper, Zimmer, Inc. (2010)
- K103662: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated LI, Zimmer, Inc. (2011) Summary page 2.
- K990135: Trilogy Acetabular System Longevity Crosslinked Polyethylene, Zimmer, Inc. (1999) Summary page 2.
- K100048: E1 Antioxidant Infused Technology, Biomet Manufacturing Corp (2010) Summary page 2.

## Most influential descendants
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K150090: Zimmer Persona Personalized Knee System (2015), 17 descendants of its own
- K172524: Zimmer Persona Personalized Knee System (2018), 15 descendants of its own
- K141635: Arthrex Ibalance Tka System (2014), 15 descendants of its own
- K122529: Zimmer Unicompartmental Knee System Vivacit-E Articular Surface (2012), 15 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K120370
Methodology: https://510kreport.com/methodology