# K091967: Medacta Bipolar Head

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 2, 2010 after 244 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.
9 later devices descend from it; 3 cite it directly.
0 of 15 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.
- K050966: Pivot Bipolar Femoral Head, Ortho Development Corp. (2005) Summary page 1.
- K014072: Fixion Unipolar Modular Hemi-Hip System (Fixion UH), Disc-O-Tech Medical Technologies, Ltd. (2002) Summary page 1.
- K982447: Plus Bipolar Prosthesis Cocrmo, Plus Orthopedics (1998) Summary page 1.

## Most influential descendants
- 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
- K241461: Mpact Constrained Liner (2025), 1 descendant of its own
- K143184: Evolve UniPolar Head (2015), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K243043: Origin™ Cemented Hip Stem (2025), 0 descendants of its own

## Indications for use
The Medacta® Bipolar Head is intended for use in combination with Medacta® Hip Prosthesis System and Mectacer femoral heads 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/K091967
Methodology: https://510kreport.com/methodology