# K242350: Spinal Alignment Solutions Pelvic Incidence (PI) Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Alignment Solutions, Inc.
- Decided: Oct 28, 2024 after 81 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: 23 generations back to K841189 (1984). 556 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 558 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 6.
- K202771: CD Horizon Spinal System, Medtronic (2020) Summary page 6.
- K221646: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM, Medtronic Sofamor Danek USA, Inc. (2022) Summary page 6.

## Most influential descendants
- K263172: SAS MIS Pelvic Incidence Rods (2026), 0 descendants of its own

## Indications for use
The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is indicated for the use with Medtronic CD Horizon™ SOLERA™ 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 (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 (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Source page: https://510kreport.com/device/K242350
Methodology: https://510kreport.com/methodology