# K142201: OMNI Interface Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Omnlife Science
- Decided: Jan 26, 2015 after 168 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: 9 generations back to K930712 (1993). 98 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112779: Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System), Omnlife Science (2011) Summary page 4.
- K060635: Consensus Acetabular Shell System, Hayes Medical, Inc. (2006) Summary page 4.
- K123782: Paragon Hip System, Global Manufacturing Technology (2013) Summary page 4.

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

## Indications for use
The OMNI Interface™ Acetabular System is designed to be used in hip arthroplasty. The specific indications for use include - Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Interface Acetabular System is intended for cementless and single use implantation only.

Source page: https://510kreport.com/device/K142201
Methodology: https://510kreport.com/methodology