# K190656: Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 6, 2019 after 267 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K810258 (1981). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161190: G7 Dual Mobility System, Active Articulation System, Biomet, Inc. (2016) Summary page 5.
- K151448: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems, Zimmer, Inc. (2015) Summary page 5.
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, Zimmer, Inc. (2012) Summary page 5.

## Most influential descendants
- K253948: Momentum Acetabular Cup System (2026), 0 descendants of its own

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0419-2026: 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 ins
- Sep 26, 2025 · Class II · Z-0418-2026: 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 ins
- Aug 14, 2020 · Class II · Z-0057-2021: The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.

## Indications for use
• 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.

Source page: https://510kreport.com/device/K190656
Methodology: https://510kreport.com/methodology