# K232650: KHEIRON® Spinal Fixation System, including patient specific K-ROD

- Pathway: 510(k) (Special)
- Applicant: S.M.A.I.O
- Decided: Sep 29, 2023 after 29 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 K040583 (2004). 416 ancestors in all.
6 later devices descend from it; 6 cite it directly.
1 of 423 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211981: KHEIRON® Spinal Fixation System, S.M.A.I.O (2022) Summary page 4.
- K223181: NuVasive Reline System, Nu Vasive, Incorporated (2023) Summary page 4.

## Most influential descendants
- K251804: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2025), 4 descendants of its own
- K253990: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 2 descendants of its own
- K253721: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2025), 2 descendants of its own
- K260786: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 1 descendant of its own
- K262828: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 0 descendants of its own

## Indications for use
The KHEIRON® Spinal Fixation System, including patient specific K-ROD, 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 instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Patient specific K-ROD devices are compatible with NuVasive Reline System components that are compatible with ø5.5mm and/or ø6.0mm rods as well as screws ø4.5mm or larger and at least 25mm in length.

Source page: https://510kreport.com/device/K232650
Methodology: https://510kreport.com/methodology