# K153336: VuePoint OCT System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jan 7, 2016 after 49 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953076 (1997). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150474: NuVasive VuePoint II OCT System, Nu Vasive, Incorporated (2015) Summary page 4.

## Most influential descendants
- K171250: BRIDALVEIL Occipital Cervical Thoracic System (2017), 1 descendant of its own
- K220570: M.U.S.T. MINI Posterior Cervical Screws System Extension (2022), 0 descendants of its own

## Indications for use
The NuVasive® VuePoint® OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VuePoint OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the VuePoint OCT System may be connected to the NuVasive SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline™ System via the rod to rod connectors or transition rods.

Source page: https://510kreport.com/device/K153336
Methodology: https://510kreport.com/methodology