# K171894: NuVasive® Precept™ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Sep 28, 2017 after 94 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 K040583 (2004). 321 ancestors in all.
No later device cites it as a predicate yet.
1 of 322 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102514: Nuvasive Spherx II -Mas Deformity Spinal System, Nuvasive, Inc. (2010) Summary page 4.
- K122352: Nuvasive Precept Spinal System, Nuvasive, Inc. (2012) Summary page 4.
- K121619: Nuvasive Polyaxial Spinal Screws, Nuvasive, Inc. (2012) Summary page 4.
- K090981: Modification to: Nuvasive Spherx System, Nuvasive, Inc. (2009) Summary page 4.
- K161014: NuVasive® Reline® System, Nu Vasive, Incorporated (2016) Summary page 4.

## Indications for use
When used as a pedicle screw fixation system, the NuVasive Precept 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 Precept 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 Precept 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. Pseudoarthrosis 7. Tumor resection and/or 8. Failed previous fusion When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Precept Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the NuVasive Precept Spinal 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/K171894
Methodology: https://510kreport.com/methodology