# K131512: Katia System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Sanyou Medical Co, Ltd.
- Decided: Aug 7, 2013 after 71 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: 7 generations back to K973854 (1998). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081038: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek (2008) Summary page 2.
- K111132: Genesys Spine Anterior Cervical Plate System, Genesys Spine (2011) Summary page 2.
- K031276: Synthes Anterior Cervical Locking Plate (Aclp) System, Synthes (Usa) (2003) Summary page 2.
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 2.

## Most influential descendants
- K163366: Shanghai Sanyou CARMEN Cervical Fusion System (2017), 0 descendants of its own

## Indications for use
The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 - Ti). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1)degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordlosis, or scoliosis), 6) pseudarthrosls, 7) failed previous fusions, and/or 8) spinal stenosis.

Source page: https://510kreport.com/device/K131512
Methodology: https://510kreport.com/methodology