# K223181: NuVasive Reline System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jan 11, 2023 after 92 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: 23 generations back to K040583 (2004). 373 ancestors in all.
11 later devices descend from it; 3 cite it directly.
1 of 385 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211958: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 5.
- K190636: NuVasive® Reline® 4.5-5.0 System, Nu Vasive, Incorporated (2019) Summary page 5.
- K132014: GSB Global Spinal Balance System, Nuvasive, Inc. (2013) 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
- K241519: Invictus® Small Stature Spinal Fixation System (2024), 2 descendants of its own

## Indications for use
When used as a pedicle screw fixation system in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis) The NuVasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline System is also intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Spinal stenosis 3. Spondylolisthesis 4. Spinal deformities 5. Fracture 6. Pseudoarthrosis 7. Tumor resection and/or 8. Failed previous fusion When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is indicated as an adjunct to fusion to treat: 1. adolescent idiopathic scoliosis. 2. progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, 3. spondylolisthesis, 4. spondylolysis, 5. pseudarthrosis, 6. failed prior fusion and 7. fracture caused by tumor and/or trauma in pediatric patients. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. In order to achieve additional levels of fixation, the NuVasive Reline System rods may be connected to the Armada System.

Source page: https://510kreport.com/device/K223181
Methodology: https://510kreport.com/methodology