# K191569: Implantcast ic-Bipolar Head System

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Aug 28, 2019 after 76 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: 7 generations back to K941847 (1994). 56 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060707: Aesculap Bipolar Acetabular Cup, Aesculap, Inc. (2006) Summary page 4.

## Most influential descendants
- K240834: EcoFit® short stem cementless cpTi (2024), 1 descendant of its own
- K223103: BethaLoc® stem cementless HA (2023), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for use
The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System for the following indications: - Proximal femur replacement in oncology cases where radical resection and replacement of bone is required. - Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required. Use of this prosthesis is generally only indicated in skeletally mature patients. The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Source page: https://510kreport.com/device/K191569
Methodology: https://510kreport.com/methodology