# K050390: Tamarack Anterior Thoracolunbar

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec/Nexmed
- Decided: Mar 14, 2005 after 26 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Z-Plate: named in the summary without a submission number

## Indications for use
The TAMARACKTM Anterior Thoracolumbar Plating System is intended for fixation to the anterolateral vertebral bodies (T10 to L5). This system is intended for implantation on one side only for the treatment of thoracic and lumbar spine instability as a result of fracture, including dislocation and subluxation, tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous fusion surgery. Warning: This device is not intended for fixation to the posterior elements (pedicle) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K050390
Methodology: https://510kreport.com/methodology