# K254247: Osteomni Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomni, Inc.
- Decided: Feb 24, 2026 after 57 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: 30 generations back to K841189 (1984). 729 ancestors in all.
No later device cites it as a predicate yet.
2 of 730 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243946: EffortMed Spinal Fixation System, Effortmed, LLC (2025) Summary page 5.

## Indications for use
Osteomni Spinal Fixation System is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the Osteomni Spinal Fixation System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: » 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, and/or lordosis) * Tumor * Pseudoarthrosis; and failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Osteomni Spinal Fixation System implants are 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 Osteomni Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The Osteomni Spinal Fixation System is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K254247
Methodology: https://510kreport.com/methodology