# K142675: CI../..X liner for NOVAE Dual Mobility Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Serf
- Decided: Jan 15, 2015 after 118 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: 7 generations back to K930712 (1993). 28 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 32 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.
- K100555: Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK, Omni Life Science, Inc. (2010) Summary page 4.

## Most influential descendants
- K211742: SignaSure Dual Mobility System (2022), 2 descendants of its own
- K220495: SignaSure Dual Mobility System (2023), 1 descendant of its own
- K243456: ONVOY™ Acetabular System (2025), 0 descendants of its own

## Indications for use
NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes: x Osteoarthritis x Femoral neck fracture x Dislocation risk x Osteonecrosis of the femoral head x 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/K142675
Methodology: https://510kreport.com/methodology