# K931655: P.F.C. Bipolar Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Orthopaedics, Inc.
- Decided: Jun 9, 1994 after 430 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.
12 later devices descend from it; 4 cite it directly.
0 of 13 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
- K100761: Biopro Polar Head (2010), 4 descendants of its own
- K100151: Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM) (2010), 4 descendants of its own
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 2 descendants of its own
- K241472: Icona Hip Stem (2024), 1 descendant of its own
- K191297: iNSitu Bipolar Hip System (2019), 1 descendant of its own

Source page: https://510kreport.com/device/K931655
Methodology: https://510kreport.com/methodology