# K211981: KHEIRON® Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: S.M.A.I.O
- Decided: Jun 9, 2022 after 349 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: 10 generations back to K992147 (2000). 80 ancestors in all.
8 later devices descend from it; 7 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201659: KHEIRON® Spinal Fixation System, S.M.A.I.O (2020) Summary page 4.
- K140738: Pass LP Spinal System, Medicrea International (2014) Summary page 5.

## Most influential descendants
- K232650: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2023), 6 descendants of its own
- 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
- K253802: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 1 descendant 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 implants are indicated as an adjunct to fusion to treat progresive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosos, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K211981
Methodology: https://510kreport.com/methodology