# K001535: Zenith Plate System, Anterior Spinal Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Tec, LLC
- Decided: Mar 20, 2001 after 307 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K103137: Venus Anterior Cervical Plate (2011), 5 descendants of its own
- K111132: Genesys Spine Anterior Cervical Plate System (2011), 4 descendants of its own
- K133245: Genesys Spine Anterior Cervical Plate II System (2014), 1 descendant of its own
- K131512: Katia System (2013), 1 descendant of its own
- K192076: Binary® Anterior Cervical Plate System (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K001535
Methodology: https://510kreport.com/methodology