# K091502: Nuvasive Spherx II System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Jul 22, 2009 after 62 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: 1 generation back to K061778 (2006). 1 ancestor in all.
153 later devices descend from it; 5 cite it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061778: Nuvasive Spherx II System, Nuvasive, Inc. (2006) Summary page 1.

## Most influential descendants
- K132014: GSB Global Spinal Balance System (2013), 82 descendants of its own
- K142499: Reline System (2014), 78 descendants of its own
- K143684: NuVasive Reline System (2015), 77 descendants of its own
- K092287: Nuvasive Spherx II - Pedicle Screw System (2009), 72 descendants of its own
- K160989: NuVasive® Reline® System (2016), 67 descendants of its own

## Indications for use
When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is intended 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 posteriorto 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 SpheRx Spinal 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), removal of the implants after attainment of a solid fusion. with When used as an anterolateral non-pedicle screw system inthe thoracic and lumbar spine, the NuVasive SpheRx Spinal 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. Pseudoarthosis 7. Tumor resection and/or 8. Failed previous fusion

Source page: https://510kreport.com/device/K091502
Methodology: https://510kreport.com/methodology