# K133381: Omni Arc Monoblock Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Omnilife Science
- Decided: Mar 13, 2014 after 129 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K941847 (1994). 122 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113242: Apex Arc Hip Stem, Omni Life Science, Inc. (2012) Summary page 1.
- K110947: Apex K1 Hip Stem, Omni Life Science, Inc. (2011) Summary page 1.

## Most influential descendants
- K172467: OMNI ARC Anteverted Neck Hip Stem (2017), 0 descendants of its own
- K171156: OMNI Anseris Hip Stem (2017), 0 descendants of its own

## Indications for use
The OMNI ARC Monoblock Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex lnterfaceTM' Acetabular System. The Apex InterfaceM Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for 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. The OMNI ARC Monoblock Hip Stem is also intended for use in hemniarthroplasty when used with the Apex Bipolar Head. The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemniarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: * Femoral neck and trochanteric fractures of the proximal femur; * Osteonecrosis of the femoral head; * Revision procedures where other treatments or devices for these indications have failed.

Source page: https://510kreport.com/device/K133381
Methodology: https://510kreport.com/methodology