# K003026: PFC Sigma Lugged Tibial Tray

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 19, 2001 after 264 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: 2 generations back to K864671 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931054: Trick Modular Knee Tibial Tray-Porous, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 2.
- K991106: P.F.C. Sigma Porous Modular Keel Tibial Tray, DePuy Orthopaedics, Inc. (1999) Summary page 2.

## Indications for use
The PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives. Caution: This knee prosthesis component is intended for cemented use only.

Source page: https://510kreport.com/device/K003026
Methodology: https://510kreport.com/methodology