# K100555: Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK

- Pathway: 510(k) (Special)
- Applicant: Omni Life Science, Inc.
- Decided: Mar 29, 2010 after 28 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: 6 generations back to K930712 (1993). 23 ancestors in all.
34 later devices descend from it; 5 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073150: Apex-LNK Poly Acetabular Cup Liners, Omni Life Science, Inc. (2008) Summary page 2.
- K000788: Apex Modular Hip Stem, Apex Surgical, LLC (2000) Summary page 2.

## Most influential descendants
- 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
- 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

## Recalls of this device
- Jul 23, 2019 · Class II · Z-2481-2019: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

## Indications for use
The Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2 or Apex K1 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total hip arthroplasty to treat 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/K100555
Methodology: https://510kreport.com/methodology