# K990959: K-Centrum Anterior Spinal Fixation System

- Pathway: 510(k) (Abbreviated)
- Applicant: Spineology, Inc.
- Decided: Dec 27, 1999 after 280 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
Longest line of descent: 1 generation back to K922543 (1993). 1 ancestor in all.
294 later devices descend from it; 2 cite it directly.
0 of 296 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922543: Z-Plate Anterior Fixation System, Sofamor Danek Mfg., Inc. (1993) Summary page 1.

## Most influential descendants
- K011556: Macs Hma Anterior Spinal Stabilization System (2001), 293 descendants of its own
- K032059: Modification to Macs Modular Anterior Construct System (2003), 250 descendants of its own
- K070387: Expedium Spine System (2007), 248 descendants of its own
- K102249: Expedium Spine System (2010), 218 descendants of its own
- K111571: Viper Systems (2011), 203 descendants of its own

## Indications for use
The K-Centrum Anterior Fixator is intended for correction and stabilization of the spine. The K-Centrum is also intended to provide temporary stabilization and augment the development of a solid spinal fusion. The K-Centrum is intended for screw/bolt/fixation attachment to the anterolateral intervertebral bodies from T10 to L5 only and less than 4 motion segments. The K-Centrum is indicated for degenerative disk disease, disk herniation, spondylosis, spondylolisthesis, burst fracture, failed surgery, corpectomy or vertebrectomy for tumor resection.

Source page: https://510kreport.com/device/K990959
Methodology: https://510kreport.com/methodology