# K121509: Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert

- Pathway: 510(k) (Traditional)
- Applicant: Tgm Medical, Inc.
- Decided: Nov 5, 2012 after 168 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: 8 generations back to K930712 (1993). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922560: Consensus (TM) Bipolar System, U.S. Medical Products, Inc. (1992) Summary page 2.
- K102399: Consensus Taperset Hip System, Consensus Orthopedics, Inc. (2010) Summary page 2.
- K111472: Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon, Tgm Medical (2011) Summary page 2.

## Indications for use
The Treasure Bipolar Head is intended for use as follows: A. Fractures of the proximal femur; B. Nonunions of proximal femoral neck fractures; C. Aseptic necrosis of the femoral head; D. Osico-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum; E. Salvage of failed total hip arthroplasty. The Treasure Bipolar Head is intended for cementless use. The Treasure Bipolar Head is intended for use with the Helicon Hip System.

Source page: https://510kreport.com/device/K121509
Methodology: https://510kreport.com/methodology