# K110947: Apex K1 Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Omni Life Science, Inc.
- Decided: Jun 16, 2011 after 73 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: 5 generations back to K932481 (1994). 10 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060072: Monoblock Press-Fit Hip Stem, Omni Life Science, Inc. (2006) Summary page 1.

## Most influential descendants
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 2 descendants of its own
- K133381: Omni Arc Monoblock Hip Stem (2014), 2 descendants of its own
- K241472: Icona Hip Stem (2024), 1 descendant of its own
- K261576: Icona Hip Stem (2026), 0 descendants of its own
- K172467: OMNI ARC Anteverted Neck Hip Stem (2017), 0 descendants of its own

## Indications for use
The Apex Hip System K1T" Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface' Acetabular System. The Apex Interface"' 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 prosthesis 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 Apex Hip System K1 Femoral 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/K110947
Methodology: https://510kreport.com/methodology