# K232719: ProMIS Extension Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Premia Spine, Ltd.
- Decided: Nov 21, 2023 after 77 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). 256 ancestors in all.
No later device cites it as a predicate yet.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231844: ProMIS™ Fixation System, Premia Spine, Ltd. (2023) Summary page 4.
- K132403: Annextm Adjacent Level System, Spine Wave, Inc. (2014) Summary page 4.

## Indications for use
When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, for the treatment of the following acute and chronic instabilities or deformities of the 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 Extension Rod System is compatible with Premia Spine's Slender Tulip Polyaxial Pedicle Screws for extending the ProMIS Fixation System to a single adjacent level.

Source page: https://510kreport.com/device/K232719
Methodology: https://510kreport.com/methodology