# K082500: Depuy Sigma CR-F Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 18, 2008 after 81 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 K943462 (1994). 2 ancestors in all.
115 later devices descend from it; 1 cites it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 1.
- K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1996) Summary page 1.

## Most influential descendants
- K101433: Depuy Attune Knee System (2010), 114 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K111433: Depuy Sttune (TM) PS Knee System (2011), 39 descendants of its own
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 26 descendants of its own
- K142404: iTotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 descendants of its own

## Indications for use
The DePuy Sigma CR-F femoral component is intended for cemented use only. Candidates for total 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.

Source page: https://510kreport.com/device/K082500
Methodology: https://510kreport.com/methodology