# K991106: P.F.C. Sigma Porous Modular Keel Tibial Tray

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 9, 1999 after 69 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 K864671 (1987). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892394: P.F.C. Modular Knee System, Tibial Tray-Porous, Johnson & Johnson Professionals, Inc. (1989) Summary page 2.
- K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1996) Summary page 2.
- K923807: P.F.C. Modular Total Knee System, Modular Plus, Johnson & Johnson International (1992) Summary page 2.
- K864671: Anatomic Modular Knee (Amk) System, Depuy, Inc. (1987) Summary page 2.
- K961379: Depuy Amk Porous Coated CRX Tibial Tray (1988-20/28-000 and 1988-20/28-501), Depuy, Inc. (1996) Summary page 2.

## Most influential descendants
- K182301: PFC SIGMA Knee System (2019), 1 descendant of its own
- K200765: Genius / Genuin Total Knee System (2021), 0 descendants of its own
- K003026: PFC Sigma Lugged Tibial Tray (2001), 0 descendants of its own

## Indications for use
The P.F.C. Sigma Porous Modular Keel Tibial Tray is indicated for use in total knee replacements 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 the result of trauma or failed prior surgical intervention. In accordance with Federal (USA) requirements, the P.F.C. Sigma Knee Modular Keel Tibial Tray is indicated for use only with PMMA bone cement.

Source page: https://510kreport.com/device/K991106
Methodology: https://510kreport.com/methodology