# K922543: Z-Plate Anterior Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek Mfg., Inc.
- Decided: May 19, 1993 after 355 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
640 later devices descend from it; 11 cite it directly.
1 of 641 devices in its family (counting itself) has 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
- K990959: K-Centrum Anterior Spinal Fixation System (1999), 294 descendants of its own
- K011556: Macs Hma Anterior Spinal Stabilization System (2001), 293 descendants of its own
- K014267: Butterfly Plate Fixation System (2002), 278 descendants of its own
- K022070: Xantus Anterior Lateral Supplemental Fixation System (2002), 277 descendants of its own
- K071416: Pyramid +4 Anterior Lumbar Spine Plate System (2007), 276 descendants of its own

Source page: https://510kreport.com/device/K922543
Methodology: https://510kreport.com/methodology