# K101451: Apex Module Hip System Biolox Delta Femoral Head

- Pathway: 510(k) (Special)
- Applicant: Omni Life Science, Inc.
- Decided: Jun 22, 2010 after 28 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: 7 generations back to K930712 (1993). 50 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012918: Apex Modular Alumina Femoral Head, Apex Surgical, LLC (2001) Summary page 2.
- K073150: Apex-LNK Poly Acetabular Cup Liners, Omni Life Science, Inc. (2008) Summary page 2.
- K100555: Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK, Omni Life Science, Inc. (2010) 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
- K241472: Icona Hip Stem (2024), 1 descendant of its own
- K261576: Icona Hip Stem (2026), 0 descendants of its own
- K171156: OMNI Anseris Hip Stem (2017), 0 descendants of its own

## Indications for use
The Apex Modular™ Ceramic Femoral Heads are intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup or bipolar component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: * Non-inflammatory degenerative joint disease, including osteoiarthritis 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/K101451
Methodology: https://510kreport.com/methodology