# K952830: Darwin Knee System (TC3)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Jan 18, 1996 after 212 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.
49 later devices descend from it; 6 cite it directly.
0 of 50 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
- K060515: Depuy PFC Sigma Knee Prosthesis (2006), 36 descendants of its own
- 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

## Recalls of this device
- Jul 18, 2018 · Class II · Z-2949-2018: This unit may be missing the screw/collet Assembly
- Sep 27, 2007 · Not classified · Z-0398-2008: 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-0399-2008: 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-0400-2008: 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-0396-2008: 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-0397-2008: 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-0401-2008: 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.
- Dec 22, 2003 · Not classified · Z-1369-04: The collar was incorrectly etched for the R (right) and L (Left) orientation

Source page: https://510kreport.com/device/K952830
Methodology: https://510kreport.com/methodology