# K152919: OMNI Skirted Heads

- Pathway: 510(k) (Traditional)
- Applicant: Omni Life Science, Inc.
- Decided: Mar 10, 2016 after 160 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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 K930712 (1993). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model, Serf (2011) Summary page 4.
- K101575: Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810, 303210,303610,304010, Omnlife Science (2010) Summary page 4.

## Most influential descendants
- K171156: OMNI Anseris Hip Stem (2017), 0 descendants of its own

## Indications for use
The OMNI Skirted Heads are intended for use in combination with the NOVAE® Dual Mobility Acetabular Cup and are indicated for total hip replacement, which includes: • Osteoarthritis • Femoral neck fracture • Dislocation risk • Osteonecrosis of the femoral head • Revision procedures where other treatments or devices have failed and if bone reconstruction so permits SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.

Source page: https://510kreport.com/device/K152919
Methodology: https://510kreport.com/methodology