# K182301: PFC SIGMA Knee System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 8, 2019 after 441 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: 4 generations back to K870730 (1987). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882234: Johnson & Johnson Modular Total Knee Prosthesis, Johnson & Johnson Professionals, Inc. (1988) Summary page 4.
- K884796: P.F.C.(TM) Modular Knee System, Johnson & Johnson Professionals, Inc. (1989) Summary page 4.
- K952830: Darwin Knee System (TC3), Johnson & Johnson Professionals, Inc. (1996) Summary page 4.
- K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1996) Summary page 4.
- K971189: P.F.C. Sigma Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1997) Summary page 4.
- K063633: Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 4.
- K062654: Depuy Sigma Cruciate Retaining Porocoat Femoral Components, DePuy Orthopaedics, Inc. (2006) Summary page 4.
- K950010: Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated, Johnson & Johnson Professionals, Inc. (1995) Summary page 4.
- K060515: Depuy PFC Sigma Knee Prosthesis, DePuy Orthopaedics, Inc. (2006) Summary page 4.
- K991106: P.F.C. Sigma Porous Modular Keel Tibial Tray, DePuy Orthopaedics, Inc. (1999) Summary page 4.
- K984158: P.F.C. Modular Plus Offset Tibial Tray, Depuy, Inc. (1999) Summary page 4.
- K032151: Depuy Sigma Tibial Inserts and CO-CR Tibial Trays, Depuy, Inc. (2003). Our reading of the summary gave K032115, FDA’s number for Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01… (Polyganics B.V.,). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “PFC SIGMA Co-Cr Tibial Tray”.

## Most influential descendants
- K200765: Genius / Genuin Total Knee System (2021), 0 descendants of its own

## Indications for use
Candidates for total or unicompartmental knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. In candidates for unicompartmental knee arthroplasty, only one side of the joint (the medial or lateral compartment) is affected. The Sigma® C/R Porocoat® Femoral Components are intended for cemented or cementless use as the femoral component of a Total Knee Replacement system. In the US, all other porous coated components have been cleared for CEMENTED USE ONLY. Any Non-Porous coated components are intended for CEMENTED USE ONLY.

Source page: https://510kreport.com/device/K182301
Methodology: https://510kreport.com/methodology