# K855231: Howmedica Bipolar Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Feb 27, 1986 after 59 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.
18 later devices descend from it; 2 cite it directly.
0 of 19 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
- K972792: Duration Stabilized Uhmwpe Acetabular Components (1997), 16 descendants of its own
- K992153: PE-Plus Acetabular Cup (1999), 15 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K141327: Minima S System (2014), 5 descendants of its own
- K152903: REVIVAL (TM) Modular Revision Hip Stem (2016), 4 descendants of its own

Source page: https://510kreport.com/device/K855231
Methodology: https://510kreport.com/methodology