# K240180: Orthopeasia Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopeasia Co., Ltd.
- Decided: Aug 30, 2024 after 220 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 K853033 (1985). 359 ancestors in all.
No later device cites it as a predicate yet.
0 of 360 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130932: Firebird Spinal Fixation System, Orthofix, Inc. (2013) Summary page 5.
- K200267: LOSPA® IS™ Spinal Fixation System, Corentec Co., Ltd. (2020) Summary page 5.

## Indications for use
The Orthopeasia Spinal Fixation System is intended to provide immobilization and stabilization of the posterior non-cervical spine (T1-S2/lllium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: - Degenerative disc disease (defied as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); - Degenerative spondylolisthesis with objective evidence of neurologic impairment; - Trauma (i.e., fracture or dislocation); - Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); - Tumor; - Stenosis; - Failed previous fusion (pseudarthrosis) The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K240180
Methodology: https://510kreport.com/methodology