# K833175: Biomet Bipolar Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 22, 1983 after 94 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
No predicates in its family tree.
26 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051569: Ringloc BI-Polar Acetabular Component (2005), 25 descendants of its own
- K060707: Aesculap Bipolar Acetabular Cup (2006), 11 descendants of its own
- K112019: Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup (2011), 10 descendants of its own
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own

Source page: https://510kreport.com/device/K833175
Methodology: https://510kreport.com/methodology