# K092443: Interface Acetabular Cup Liners

- Pathway: 510(k) (Special)
- Applicant: Omni Life Science, Inc.
- Decided: Oct 23, 2009 after 74 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: 6 generations back to K930712 (1993). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031110: Apex Modular Acetabular Cup, Apex Surgical, LLC (2003) Summary page 2.
- K062489: Apex Hcla Acetabular Cup  Liners, Omnilife Science (2007) Summary page 2.
- K073150: Apex-LNK Poly Acetabular Cup Liners, Omni Life Science, Inc. (2008) Summary page 2.
- K934765: Trilogy Acetabular System, Zimmer, Inc. (1994) Summary page 2.
- K953490: Trilogy Acetabular Shell & Liners 36MM, Zimmer, Inc. (1995) Summary page 2.
- K972774: Gas Plasma Sterilization, Zimmer, Inc. (1999) Summary page 2.

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

## Indications for use
The InterfaceTM Acetabular Cup Liners are intended for use with the InterfaceTM Acetabular Cup, in combination with the Apex ModularTM, Apex K2TM, or Apex K1TM Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: * 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.

Source page: https://510kreport.com/device/K092443
Methodology: https://510kreport.com/methodology