# K221776: NextGen Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Aug 9, 2022 after 49 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: 21 generations back to K003155 (2001). 628 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 631 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210539: CoreLink Midline Fixation System, Corelink, LLC (2021) Summary page 5.
- K211323: ASTRA Spine System, Spinecraft, LLC (2021) Summary page 5.
- K180179: Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw, Orthofix, Inc. (2018) Summary page 5.

## Most influential descendants
- K231494: CoreLink Robotic Navigation Instruments (2023), 0 descendants of its own
- K230880: CoreLink Navigation Instruments (2023), 0 descendants of its own

## Indications for use
The CoreLink NextGen Pedicle Screw System 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/iliac spine (T1 – S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used for posterior non-cervical screw fixation in pediatric patients, the CoreLink NextGen Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CoreLink NextGen Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric 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/K221776
Methodology: https://510kreport.com/methodology