# K935452: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Orthopaedics, Inc.
- Decided: Oct 6, 1994 after 328 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
213 later devices descend from it; 2 cite it directly.
0 of 214 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
- K945518: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component (1996), 212 descendants of its own
- K961939: S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) (1996), 210 descendants of its own
- K974331: Uni-Rom Total Hip System Femoral Stem (1998), 189 descendants of its own
- K001991: Titan Porocoat Hip Prosthesis (2000), 188 descendants of its own
- K042992: Corail Amt Hip Prosthesis (2005), 168 descendants of its own

Source page: https://510kreport.com/device/K935452
Methodology: https://510kreport.com/methodology
