# K994347: Centaur Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 15, 2000 after 83 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 K983583 (1998). 1 ancestor in all.
343 later devices descend from it; 5 cite it directly.
0 of 345 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.

## Most influential descendants
- K002824: Macs Modular Anterior Construct System (2001), 254 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
When used as an anterior, thoracic/lumbar screw fixation system, the Centaur™ Spinal System is intended to treat deformities of curvature (i.e. scoliosis, kyphosis and/or lordosis), fracture, tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e.discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies). Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K994347
Methodology: https://510kreport.com/methodology