# K100151: Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM)

- Pathway: 510(k) (Traditional)
- Applicant: Omnlife Science
- Decided: May 28, 2010 after 129 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953510 (1995). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60), Omni Life Science, Inc. (2009) Summary page 1.
- K945793: P.F.C.(R) Bipolar Hip System - 22MM Bipolar, Johnson & Johnson Professionals, Inc. (1995) Summary page 1.
- K931655: P.F.C. Bipolar Hip System, Johnson & Johnson Orthopaedics, Inc. (1994) 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 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 devices or treatments for these indications have failed.

Source page: https://510kreport.com/device/K100151
Methodology: https://510kreport.com/methodology