# K170342: Ocata Anterior Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Direct, LLC
- Decided: May 9, 2017 after 95 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: 3 generations back to K926453 (1993). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010466: Tether Acfs, Theken Surgical,Llc (2001) Summary page 4.
- K032368: Sonoma Anterior Cervical Plate System, Seaspine (2003) Summary page 4.
- K062310: Reflex Hybrid Acp System, Stryker Spine (2006) Summary page 4.
- K040261: Reflex Hybrid Anterior Cervical Plate System, Stryker Spine (2004) Summary page 4.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.

## Most influential descendants
- K172086: Matira™ Anterior Cervical System (2017), 0 descendants of its own

## Indications for use
The Ocata™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures and dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis, or scoliosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device system is intended for anterior cervical intervertebral body fusions only. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K170342
Methodology: https://510kreport.com/methodology