# K231443: Mini-OSTEO Pedicle Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Indústria E Comércio DE Implantes Ltda
- Decided: Nov 21, 2023 after 187 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: 20 generations back to K040583 (2004). 541 ancestors in all.
No later device cites it as a predicate yet.
1 of 542 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162494: CD HORIZON® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4.
- K122226: Revere Stabilization System, Globus Medical, Inc. (2012) Summary page 4.
- K190636: NuVasive® Reline® 4.5-5.0 System, Nu Vasive, Incorporated (2019) Summary page 4.
- K222229: Advanced LumFix Spinal Fixation System, CG Bio Co., Ltd. (2023). Cleared while this submission was under review Summary page 4.
- K223096: Dark Star Deformity Pedicle Screw System, Republic Spine, LLC (2023). Cleared while this submission was under review Summary page 4.

## Indications for use
The Mini-OSTEO Pedicle Fixation System is intended for posterior, non-cervical pedicle fixation of the spine 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 the thoracic, lumbar, and/or sacral spine: 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/or failed previous fusion.

Source page: https://510kreport.com/device/K231443
Methodology: https://510kreport.com/methodology