# K231844: ProMIS™ Fixation System

- Pathway: 510(k) (Special)
- Applicant: Premia Spine, Ltd.
- Decided: Jul 7, 2023 after 15 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 K853033 (1985). 102 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150380: ProMIS Fixation System, Premia Spine, Ltd. (2015) Summary page 4.

## Most influential descendants
- K232719: ProMIS Extension Rod System (2023), 0 descendants of its own

## Indications for use
The ProMIS™ Fixation 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 instabilties or deformities of the 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimal invasive (MIS) instrumentation.

Source page: https://510kreport.com/device/K231844
Methodology: https://510kreport.com/methodology