# K252139: Kentrospine Viktr-MIS® Pedicle screw system

- Pathway: 510(k) (Traditional)
- Applicant: Rivarp Medical Pvt., Ltd.
- Decided: Sep 27, 2026 after 446 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: 11 generations back to K950697 (1995). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183117: PathLoc-L MIS Spinal System, L&K BIOMED Co., Ltd. (2018) Summary page 5.

## Indications for use
The Kentrospine Viktr-MIS® 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 acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The Kentrospine Viktr-MIS® Pedicle screw system is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with 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/or lordosis); Tumor; Pseudarthrosis; and/or failed previous fusion. The Kentrospine Viktr-MIS® Pedicle screw system can be used in an open approach and a percutaneous approach with Kentrospine Viktr-MIS® Pedicle screw system instruments.

Source page: https://510kreport.com/device/K252139
Methodology: https://510kreport.com/methodology