# K100761: Biopro Polar Head

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Dec 3, 2010 after 261 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953510 (1995). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082705: Biopro Bipolar Head, Models 18130-18152, Biopro, Inc. (2008) Summary page 1.
- 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
- 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
- K143113: Klassic BiPolar System (2015), 0 descendants of its own

## Recalls of this device
- Sep 9, 2025 · Class II · Z-0150-2026: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

## Indications for use
The BioPro Bipolar Head is intended for use in combination with a BioPro PSL femoral stem for 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/K100761
Methodology: https://510kreport.com/methodology