# K062489: Apex Hcla Acetabular Cup  Liners

- Pathway: 510(k) (Traditional)
- Applicant: Omnilife Science
- Decided: Aug 15, 2007 after 355 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: 2 generations back to K972596 (1997). 4 ancestors in all.
63 later devices descend from it; 5 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994415: Marathon Cross-Linked Polyethylene Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2000) Summary page 2.
- K010171: Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner, DePuy Orthopaedics, Inc. (2001) Summary page 2.
- K033273: Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads, DePuy Orthopaedics, Inc. (2004) Summary page 2.

## Most influential descendants
- K073150: Apex-LNK Poly Acetabular Cup Liners (2008), 62 descendants of its own
- K100555: Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK (2010), 34 descendants of its own
- K100445: Klassic HD Hip System (2010), 25 descendants of its own
- K101575: Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810, 303210,303610,304010 (2010), 24 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 descendants of its own

## Indications for use
The Apex HCLA Acetabular Cup Liners are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, or Apex K1 Hip Stem in total hip replacement procedures. The acetabular cup liners are 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: * Femnoral neck and trochanteric fractures of the proximal femur.

Source page: https://510kreport.com/device/K062489
Methodology: https://510kreport.com/methodology