# K263172: SAS MIS Pelvic Incidence Rods

- Pathway: 510(k) (Special)
- Applicant: Spinal Alignment Solutions, Inc.
- Decided: Sep 30, 2026 after 20 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: 24 generations back to K841189 (1984). 557 ancestors in all.
No later device cites it as a predicate yet.
0 of 558 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242350: Spinal Alignment Solutions Pelvic Incidence (PI) Rod System, Spinal Alignment Solutions, Inc. (2024) Summary page 6.

## Indications for use
The Spinal Alignment Solutions MIS Pl-Rod is indicated for the use with Medtronic CD Horizon TM SOLERA TM Spinal System which is intended for posterior, lumbar and sacral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DOD - 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Source page: https://510kreport.com/device/K263172
Methodology: https://510kreport.com/methodology