# K062654: Depuy Sigma Cruciate Retaining Porocoat Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Sep 29, 2006 after 22 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- 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 K933787 (1994). 3 ancestors in all.
120 later devices descend from it; 6 cite it directly.
0 of 124 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.
- K933787: Porocoat Porous Coating/Aml Proximally-Coated Stem, Depuy, Inc. (1994) Summary page 1.

## Most influential descendants
- K073602: Modification to: Apex Knee System (2008), 72 descendants of its own
- K080842: Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] (2008), 61 descendants of its own
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere (2013), 60 descendants of its own
- K101499: Journey CR Knee System (2010), 45 descendants of its own
- K121443: Journey II CR Knee System (2012), 37 descendants of its own

## Indications for use
The Sigma Cruciate Retaining Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system. Total Knee Replacement is intended to provide increased patient 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 knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and kneejoint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in their quality of life.

Source page: https://510kreport.com/device/K062654
Methodology: https://510kreport.com/methodology