# K060515: Depuy PFC Sigma Knee Prosthesis

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 23, 2006 after 24 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: 3 generations back to K870730 (1987). 11 ancestors in all.
36 later devices descend from it; 5 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040281: LPS Metaphyseal Sleeve (Limb Preservation System), DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K952830: Darwin Knee System (TC3), Johnson & Johnson Professionals, Inc. (1996) Summary page 1.

## Most influential descendants
- K201023: iTotal® Identity Posterior Stabilized Knee Replacement System (2020), 14 descendants of its own
- K110404: Eaum Total Knee System (2012), 14 descendants of its own
- K203447: iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement (2020), 12 descendants of its own
- K210191: Identity Imprint Knee Replacement System (2021), 10 descendants of its own
- K121037: Lospa Tibial Base Plate (2012), 10 descendants of its own

## Indications for use
The PFC® Sigma Total Knee Prosthesis is intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The PFC Sigma Total Knee Prosthesis is intended for cemented use only.

Source page: https://510kreport.com/device/K060515
Methodology: https://510kreport.com/methodology