# K112779: Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)

- Pathway: 510(k) (Special)
- Applicant: Omnlife Science
- Decided: Dec 2, 2011 after 67 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930712 (1993). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 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 1.

## Most influential descendants
- K142201: OMNI Interface Acetabular System (2015), 1 descendant of its own
- K171156: OMNI Anseris Hip Stem (2017), 0 descendants of its own

## Recalls of this device
- Jun 4, 2015 · Class II · Z-2445-2015: The device may have improper screw hole placement due to inaccurate location of the index line.

## Indications for use
The Apex Interface™ Acetabular System is intended for use in combination with the Apex Modular 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 uncemented fixation and 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/K112779
Methodology: https://510kreport.com/methodology
