# K943462: Darwin Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Dec 21, 1994 after 156 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: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
428 later devices descend from it; 12 cite it directly.
0 of 429 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033272: Depuy Sigma Tibial Inserts (2004), 351 descendants of its own
- K040166: Depuy Sigma XLK Tibial Inserts (2004), 324 descendants of its own
- K052472: Depuy Global Shoulder Crosslink Glenoid (2005), 158 descendants of its own
- K062654: Depuy Sigma Cruciate Retaining Porocoat Femoral Components (2006), 120 descendants of its own
- K032151: Depuy Sigma Tibial Inserts and CO-CR Tibial Trays (2003), 118 descendants of its own

## Recalls of this device
- Dec 9, 2013 · Class II · Z-1077-2014: Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This d
- May 7, 2009 · Not classified · Z-1686-2009: There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant.
- Sep 27, 2007 · Not classified · Z-0406-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0402-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0403-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0407-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0404-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0405-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

Source page: https://510kreport.com/device/K943462
Methodology: https://510kreport.com/methodology