# K002619: Newgen System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Nov 16, 2000 after 85 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
597 later devices descend from it; 3 cite it directly.
0 of 598 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
- K014263: Newgen/Universal Mandibular System (2002), 596 descendants of its own
- K030448: Osteomed 2.0 Locking Plates and Screws (2003), 444 descendants of its own
- K032442: KLS-Martin Mandibular/Reconstruction System II (2003), 435 descendants of its own
- K040598: KLS Martin Hand Plating System (2004), 360 descendants of its own
- K050868: Maxlock (2005), 343 descendants of its own

Source page: https://510kreport.com/device/K002619
Methodology: https://510kreport.com/methodology