# K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60)

- Pathway: 510(k) (Traditional)
- Applicant: Omni Life Science, Inc.
- Decided: Feb 18, 2009 after 175 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: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953510 (1995). 2 ancestors in all.
21 later devices descend from it; 6 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982447: Plus Bipolar Prosthesis Cocrmo, Plus Orthopedics (1998) Summary page 2.

## Cited in the summary but kept off the family tree
- K050888: Integra Immobilization System, Diacor, Inc. (2005). Our OCR of the scanned summary read K050888, FDA’s number for Integra Immobilization System (Diacor, Inc.), which shares no word with the summary’s name for the device, “Pivol Bipolar Femoral Head”, apart from generic ones like “system”. Kept off the family tree.
- K082705: Biopro Bipolar Head, Models 18130-18152, Biopro, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K091967: Medacta Bipolar Head (2010), 9 descendants of its own
- K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE (2014), 5 descendants of its own
- K100761: Biopro Polar Head (2010), 4 descendants of its own
- K100151: Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM) (2010), 4 descendants of its own
- K183114: Corin BiPolar-i (2019), 3 descendants of its own

## Recalls of this device
- Jul 10, 2009 · Not classified · Z-1972-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1984-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1986-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1975-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1969-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1977-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1987-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1973-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1983-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1978-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1985-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1967-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1980-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1968-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1971-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1976-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1966-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1982-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1981-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1974-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1970-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1979-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
- Jul 10, 2009 · Not classified · Z-1988-2009: The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.

## 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 hemiarthroplasty 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/K082468
Methodology: https://510kreport.com/methodology