# K900638: P.F.C. Hip System Non-Porous Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson International
- Decided: Apr 30, 1990 after 80 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.
37 later devices descend from it; 1 cites it directly.
0 of 38 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
- K013352: Summit Cemented Hip Prosthesis (2001), 36 descendants of its own
- K023453: Depuy Summit FX Cemented Hip Prosthesis (2002), 29 descendants of its own
- K170339: Summit Hip System (2018), 27 descendants of its own
- K193398: Summit DuoFix HA Coating (2020), 20 descendants of its own
- K202472: ACTIS Duofix Hip Prosthesis (2020), 15 descendants of its own

Source page: https://510kreport.com/device/K900638
Methodology: https://510kreport.com/methodology