# K071435: Nuvasive Oct System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Aug 6, 2007 after 75 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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
No predicates in its family tree.
35 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K133556: Virage Oct Spinal Fixation System (2014), 27 descendants of its own
- K171444: YUKON OCT Spinal System (2017), 13 descendants of its own
- K150918: PASS OCT Spinal System (2015), 13 descendants of its own
- K093319: Nuvasive Vuepoint Oct System (2010), 10 descendants of its own
- K182182: YUKON OCT Spinal System (2018), 5 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), the NuVasive OCT System 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 NuVasive OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors.

Source page: https://510kreport.com/device/K071435
Methodology: https://510kreport.com/methodology