# K183457: Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 5, 2019 after 327 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). 78 ancestors in all.
No later device cites it as a predicate yet.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953337: Beta Hip Prosthesis, Zimmer, Inc. (1996) Summary page 5.
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32, Biomet, Inc. (2015) Summary page 5.
- K121874: G7 Acetabular System, Biomet Manufacturing Corp (2012) Summary page 5.

## Indications for use
The Zimmer Biomet 12/14 CoCr Femoral Heads are intended for use in total and hemi arthroplasty* in primary and revision patients. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct. * Hemi-Arthroplasty indication is for use with Bipolar Systems only. The Zimmer Biomet 12/14 CoCr Freedom® Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

Source page: https://510kreport.com/device/K183457
Methodology: https://510kreport.com/methodology