# K902365: Modular Unipolar System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jan 11, 1991 after 226 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
185 later devices descend from it; 4 cite it directly.
0 of 186 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
- K960538: Opteon Unipolar (1996), 121 descendants of its own
- K984028: The New Bio-Moore Endo Heads (1999), 117 descendants of its own
- K042037: M2A Magnum System (2004), 116 descendants of its own
- K053536: Durom Acetabular Component and Metasul LDH Large Diameter Heads (2006), 74 descendants of its own
- K071723: Zimmer Porolock Mis Stem (2008), 73 descendants of its own

Source page: https://510kreport.com/device/K902365
Methodology: https://510kreport.com/methodology