# K132122: Kestrel Posterior Cervical Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Omni Surgical, LLC Dba Spine360
- Decided: Jan 22, 2014 after 196 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033961 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061943: Anatomica Posterior Cervical Fixation System, Anatomica AB (2007) Summary page 1.

## Most influential descendants
- K181350: ASTRA-OCT Spine System (2018), 0 descendants of its own

## Indications for use
The Kestrel Posterior Cervical Fixation System is intended to promote fiusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications: * Degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies * Spondylolisthesis * Trauma (i.e fracture or dislocation) * Spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and /or lordosis) * Tumor * Pseudoarthrosis * Failed previous fusion Occipital bone screws are limited to occipital fixation only. Pedicle screws are limited to placement in the upper thoracic spine (TI -T3), when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fission for the occipital/cervical loop.

Source page: https://510kreport.com/device/K132122
Methodology: https://510kreport.com/methodology