# K230325: GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Greens Surgicals Pvt., Ltd.
- Decided: Oct 10, 2024 after 612 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: 18 generations back to K003155 (2001). 328 ancestors in all.
No later device cites it as a predicate yet.
1 of 329 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121342: Xia 4.5 Spinal System, Stryker Corp. (2012) Summary page 6.
- K152457: CD HORIZON Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6.
- K150896: Vitality Spinal Fixation System, Zimmer Spine, Inc. (2015) Summary page 6.

## Indications for use
The GREENS BRAND Posterior, Non‐cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for 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 sacral spine: • Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) • Spondylolisthesis • Trauma (e.g., fracture or dislocation) • Deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis) • Tumor • Spinal stenosis • Pseudarthrosis • Failed previous fusion Paediatric Use: When used for posterior non‐cervical screw fixation in paediatric patients, the GREENS BRAND Posterior, Non‐cervical Pedicle Screw Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, it is intended to treat paediatric patients diagnosed with the following conditions: • Spondylolisthesis • Spondylolysis • Fracture caused by tumor and/or trauma. Paediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K230325
Methodology: https://510kreport.com/methodology