# K923807: P.F.C. Modular Total Knee System, Modular Plus

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson International
- Decided: Nov 9, 1992 after 103 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K984158: P.F.C. Modular Plus Offset Tibial Tray (1999), 7 descendants of its own
- K013906: HLS Noetos System (2002), 3 descendants of its own
- K991106: P.F.C. Sigma Porous Modular Keel Tibial Tray (1999), 3 descendants of its own
- K182301: PFC SIGMA Knee System (2019), 1 descendant of its own
- K094013: HLS Kneetec System (2011), 1 descendant of its own

## Recalls of this device
- Jan 15, 2004 · Not classified · Z-1382-04: Screw size included in system was incorrect

Source page: https://510kreport.com/device/K923807
Methodology: https://510kreport.com/methodology