# K950010: Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: May 15, 1995 after 132 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: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
365 later devices descend from it; 10 cite it directly.
0 of 366 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
- K101433: Depuy Attune Knee System (2010), 114 descendants of its own
- K092122: Global Shoulder Steptech Anchor Peg Glenoid (2009), 75 descendants of its own

## Recalls of this device
- Sep 27, 2007 · Not classified · Z-0385-2008: 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-0387-2008: 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-0388-2008: 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-0391-2008: 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-0393-2008: 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-0395-2008: 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-0422-2008: 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-0386-2008: 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-0389-2008: 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-0390-2008: 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-0392-2008: 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-0394-2008: 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-0418-2008: 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-0419-2008: 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-0420-2008: 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-0421-2008: 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/K950010
Methodology: https://510kreport.com/methodology