# K082332: Nuvasive Spherx System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Oct 10, 2008 after 57 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SpheRx® HI System: named in the summary without a submission number

## Recalls of this device
- Jan 5, 2009 · Class II · Z-0348-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0355-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0359-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0366-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0368-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0372-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0357-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0358-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0360-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0364-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0367-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0370-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0373-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0349-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0351-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0353-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0362-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0365-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0369-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0371-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0374-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0375-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0376-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0377-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0350-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0352-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0354-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0356-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0361-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0363-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.
- Jan 5, 2009 · Class II · Z-0378-2013: The tulip portion of the screw assembly can disengage from the shank after implantation.

## Indications for use
When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal 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 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 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), 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 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/K082332
Methodology: https://510kreport.com/methodology