# K945518: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Mar 8, 1996 after 485 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
Longest line of descent: 1 generation back to K935452 (1994). 1 ancestor in all.
212 later devices descend from it; 3 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)
- K935452: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K082525: Corin Metafix Femoral Stem (2010), 71 descendants of its own

## Indications for use
The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use in total and partial hip replacement procedures for patients suffering severe pain and disability due to structural damage tn the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of a prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion. The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use without bone cement (PMMA).

Source page: https://510kreport.com/device/K945518
Methodology: https://510kreport.com/methodology