# K984158: P.F.C. Modular Plus Offset Tibial Tray

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jan 28, 1999 after 70 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884796 (1989). 4 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884796: P.F.C.(TM) Modular Knee System, Johnson & Johnson Professionals, Inc. (1989) Summary page 2.
- K892394: P.F.C. Modular Knee System, Tibial Tray-Porous, Johnson & Johnson Professionals, Inc. (1989) Summary page 2.
- K923807: P.F.C. Modular Total Knee System, Modular Plus, Johnson & Johnson International (1992) Summary page 2.
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 2.

## Most influential descendants
- K013906: HLS Noetos System (2002), 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
- K241000: ATTUNE™ Revision Knee System;  DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System; (2024), 0 descendants of its own
- K200765: Genius / Genuin Total Knee System (2021), 0 descendants of its own

## Indications for use
The P.E.C.® Modular Total Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout. This damage may also be a result of trauma or failed prior surgical intervention. The P.F.C.® Modular Plus Offset Tibial Tray is indicated for use with polymethylmethacrylate (PMMA) bone cement.

Source page: https://510kreport.com/device/K984158
Methodology: https://510kreport.com/methodology