# K182059: Prase MIS Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Gbs Commonwealth Co., Ltd.
- Decided: Oct 4, 2018 after 65 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: 12 generations back to K990745 (1999). 133 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161766: PathLoc-L MIS Spinal System, L&K BIOMED Co., Ltd. (2016) Summary page 4.
- K173645: JASPER Spinal Fixation System, Gbs Commonwealth Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K190762: The JASPER Spinal Fixation System II (2019), 1 descendant of its own
- K232292: Peridot-EX Expandable Intervertebral Body Fusion System (2023), 0 descendants of its own

## Indications for use
The Prase MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Prase MIS Spinal System can be used in an open approach and a percutaneous approach. The Prase MIS Spinal System is intended for the following indications: • Degenerative disc disease (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 for lordosis) • Tumor • Pseudarthrosis • Failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K182059
Methodology: https://510kreport.com/methodology