# K220285: PINE Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Tdm Co., Ltd.
- Decided: May 19, 2022 after 107 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K990745 (1999). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 5.
- K111362: Rexious Spinal Fixation System, Dio Medical Co., Ltd. (2011) Summary page 5.
- K173131: Rexious Spinal Fixation System, Huvexel Co., Ltd. (2017) Summary page 5.
- K160731: LumFix Spinal Fixation Sytem, CG Bio Co., Ltd. (2016) Summary page 5.

## Indications for use
PINE Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute or chronic spinal instabilities or deformities in the thoracic, lumbar, and sacral spine: - Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies - Spondylolisthesis - Trauma (i.e., fracture or dislocation) - Spinal stenosis - Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion

Source page: https://510kreport.com/device/K220285
Methodology: https://510kreport.com/methodology