# K082705: Biopro Bipolar Head, Models 18130-18152

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Dec 15, 2008 after 90 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: 2 generations back to K953510 (1995). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050966: Pivot Bipolar Femoral Head, Ortho Development Corp. (2005) Summary page 2.
- K982447: Plus Bipolar Prosthesis Cocrmo, Plus Orthopedics (1998) Summary page 2.

## Most influential descendants
- K100761: Biopro Polar Head (2010), 4 descendants of its own
- K191297: iNSitu Bipolar Hip System (2019), 1 descendant of its own
- K243192: iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (2026), 0 descendants of its own
- K243634: Maxx Libertas Bipolar Hip Head (Bipolar Hip) (2025), 0 descendants of its own
- K171156: OMNI Anseris Hip Stem (2017), 0 descendants of its own

## Indications for use
The BioPro Bipolar Head is intended for use in combination with a BioPro PSL Hip System femoral stem for uncemented primary or revision arthroplasty 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/K082705
Methodology: https://510kreport.com/methodology