# K093319: Nuvasive Vuepoint Oct System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Jun 23, 2010 after 243 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K853033 (1985). 20 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071435: Nuvasive Oct System, Nuvasive, Inc. (2007) Summary page 1.
- K092287: Nuvasive Spherx II - Pedicle Screw System, Nuvasive, Inc. (2009) Summary page 1.
- K080828: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- K180198: NuVasive® VuePoint® II OCT System (2018), 4 descendants of its own
- K133374: Streamline Oct Occipito-Cervico-Thoracic System (2014), 3 descendants of its own
- K191553: NuVaisve® Reline® Cervical System (2019), 2 descendants of its own
- K150254: Streamline OCT Occipito-Cervico-Thoracic System (2015), 2 descendants of its own
- K213654: NuVasive Reline Cervical System (2022), 1 descendant of its own

## Indications for use
The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and is indicated for: (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/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal tumor and/or (8) Revision of previous cervical spine surgery. The occipital bone screws are limited to occipital fixation only. The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The VuePoint OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors or transition rods.

Source page: https://510kreport.com/device/K093319
Methodology: https://510kreport.com/methodology