# K190660: G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 5, 2019 after 266 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 11 generations back to K810258 (1981). 87 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32, Biomet, Inc. (2015) Summary page 5.
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, Zimmer, Inc. (2012) Summary page 5.
- K151448: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems, Zimmer, Inc. (2015) Summary page 5.
- K990135: Trilogy Acetabular System Longevity Crosslinked Polyethylene, Zimmer, Inc. (1999) Summary page 5.
- K003758: Allofit Acetabular System, Sulzer Orthopedics, Inc. (2001) Summary page 5.

## Most influential descendants
- K261453: G7® Acetabular System (2026), 0 descendants of its own
- K253948: Momentum Acetabular Cup System (2026), 0 descendants of its own
- K252067: Velora Acetabular System (2025), 0 descendants of its own
- K243456: ONVOY™ Acetabular System (2025), 0 descendants of its own

## 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. Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.

Source page: https://510kreport.com/device/K190660
Methodology: https://510kreport.com/methodology