# K262828: KHEIRON® Spinal Fixation System, including patient specific K-ROD

- Pathway: 510(k) (Special)
- Applicant: S.M.A.I.O
- Decided: Sep 4, 2026 after 25 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: 34 generations back to K841189 (1984). 1,041 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,042 devices in its family (counting itself) have 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 5.
- K253802: KHEIRON® Spinal Fixation System, including patient specific K-ROD, S.M.A.I.O (2026) Summary page 5.
- K171421: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System, Silony Medical GmbH (2018) Summary page 5.
- K222110: Mariner RDX System, SeaSpine Orthopedics Corporation (2022) Summary page 5.
- K251804: KHEIRON® Spinal Fixation System, including patient specific K-ROD, S.M.A.I.O (2025) Summary page 5.
- K240539: Vital™ Spinal Fixation System, Zimvie Spine (Zimmer Biomet Spine, Inc.) (2024) Summary page 6.
- K253721: KHEIRON® Spinal Fixation System, including patient specific K-ROD, S.M.A.I.O (2025) Summary page 6.
- K200245: EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System, Medos International Sàrl (2020) Summary page 6.
- K231479: TriALTIS Spine System, Medos International SARL (2023) Summary page 6.
- K253990: KHEIRON® Spinal Fixation System, including patient specific K-ROD, S.M.A.I.O (2026) Summary page 6.
- K250908: Virata Spinal Fixation System, SeaSpine Orthopedics Corporation (2025) Summary page 6.
- K260786: KHEIRON® Spinal Fixation System, including patient specific K-ROD, S.M.A.I.O (2026) Summary page 6.
- K232650: KHEIRON® Spinal Fixation System, including patient specific K-ROD, S.M.A.I.O (2023) Summary page 6.

## Indications for use
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, 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, nheuromuscular scoliosis, and congenital scoliosis. Additionally, 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. When connected to compatible pedicle screw systems, the 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. Please refer to the additional information section of the most up-to-date Instructions for Use on compatible pedicle screw systems.

Source page: https://510kreport.com/device/K262828
Methodology: https://510kreport.com/methodology