# K014263: Newgen/Universal Mandibular System

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments
- Decided: Mar 8, 2002 after 71 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002619 (2000). 1 ancestor in all.
596 later devices descend from it; 5 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)
- K002619: Newgen System, Stryker Instruments (2000) Summary page 1.

## Most influential descendants
- 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
- K073624: Modular Foot System (2008), 342 descendants of its own

## Recalls of this device
- Sep 19, 2008 · Not classified · Z-0610-2009: A template is supposed to accompany the product, but it was not included with this lot.

## Indications for use
The Stryker Leibinger Newgen/Universal Mandibular System is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction.

Source page: https://510kreport.com/device/K014263
Methodology: https://510kreport.com/methodology