# K212512: G7® Vivacit-E® Freedom® Constrained Liner

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 28, 2022 after 261 days
- Product code: PBI (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive)
- Device class: 2
- Regulation: 21 CFR 888.3310
- 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). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121874: G7 Acetabular System, Biomet Manufacturing Corp (2012) Summary page 5.
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32, Biomet, Inc. (2015) Summary page 5.

## Indications for use
1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques 5) 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. Indications for G7® Vivacit-E® Freedom® Constrained Liner: The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

Source page: https://510kreport.com/device/K212512
Methodology: https://510kreport.com/methodology