# K101575: Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810, 303210,303610,304010

- Pathway: 510(k) (Special)
- Applicant: Omnlife Science
- Decided: Jun 30, 2010 after 23 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: 7 generations back to K930712 (1993). 24 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000788: Apex Modular Hip Stem, Apex Surgical, LLC (2000) Summary page 1.
- K073150: Apex-LNK Poly Acetabular Cup Liners, Omni Life Science, Inc. (2008) Summary page 1.
- K100555: Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK, Omni Life Science, Inc. (2010) Summary page 1.

## Most influential descendants
- K103721: Mpact Acetabular System (2011), 21 descendants of its own
- K122641: Mpact Extension (2012), 14 descendants of its own
- K132879: Mpact Extension (2014), 11 descendants of its own
- K183582: MPACT Extension (2019), 4 descendants of its own
- K230011: Mpact Extension (2023), 3 descendants of its own

## Indications for use
The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetaboular cup are intended for uncemented fixation and single use implantation. These prostheses may be used for the following conditions, as appropriate: * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; * Rheumatoid arthritis; * Cortection of functional deformity; * Congenital dislocation; * Revision procedures where other treatments or devices have tailed; * Femoral neck and trochanteric fractures of the proximal femur.

Source page: https://510kreport.com/device/K101575
Methodology: https://510kreport.com/methodology