# K192680: Percusys® Plus Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Joimax GmbH
- Decided: Dec 18, 2019 after 83 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: 15 generations back to K853033 (1985). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143200: MIS Z-Pedicle Screw System, Z-Medical GmbH & Co. KG (2015) Summary page 4.

## Indications for use
The Percusys® Plus 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 and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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 (1.e., scoliosis, kyphosis, and/or lordosis); fumor; pseudoarthrosis; and failed previous fusion

Source page: https://510kreport.com/device/K192680
Methodology: https://510kreport.com/methodology