# K180226: TREND II Spinal Fixation System- STEP Series

- Pathway: 510(k) (Traditional)
- Applicant: Paonan Biotech Co., Ltd.
- Decided: Jul 25, 2018 after 180 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: 16 generations back to K990745 (1999). 171 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161225: Paonan Armstrong Posterior Spinal Fixation System, Paonan Biotech Co., Ltd. (2017) Summary page 4.
- K051704: Mykres Spinal System, Showa Ika Kohgyo Co., Ltd. (2006) Summary page 4.

## Most influential descendants
- K240233: Pitkar Spinal Pedicle Screw System (2024), 0 descendants of its own

## Indications for use
TREND II Spinal Fixation System - STEP Series is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1-Sacrum/Ilium) 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 - Degenerative SpondylRlisthesis with objective evidence of neurologic impairment - Fractures - Dislocation - Scoliosis - Kyphosis - Spinal tumor - Failed previous fusion (pseudarthrosis)

Source page: https://510kreport.com/device/K180226
Methodology: https://510kreport.com/methodology