# K191297: iNSitu Bipolar Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Companies, LLC
- Decided: Sep 17, 2019 after 126 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: 4 generations back to K953510 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites 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)
- K082705: Biopro Bipolar Head, Models 18130-18152, Biopro, Inc. (2008) Summary page 4.
- K100761: Biopro Polar Head, Biopro, Inc. (2010) Summary page 4.

## Most influential descendants
- K243192: iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (2026), 0 descendants of its own

## Recalls of this device
- Sep 11, 2025 · Class II · Z-0227-2026: Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

## Indications for use
The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stems 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; • Revisions procedures where other devices or treatments for these indications have failed

Source page: https://510kreport.com/device/K191297
Methodology: https://510kreport.com/methodology