# K213654: NuVasive Reline Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Feb 23, 2022 after 96 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: 20 generations back to K040583 (2004). 330 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 332 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191553: NuVaisve® Reline® Cervical System, Nu Vasive, Incorporated (2019) Summary page 4.
- K180198: NuVasive® VuePoint® II OCT System, Nu Vasive, Incorporated (2018) Summary page 4.
- K093319: Nuvasive Vuepoint Oct System, Nuvasive, Inc. (2010) Summary page 4.

## Most influential descendants
- K221388: NuVasive Reline Cervical System (2022), 0 descendants of its own

## Indications for use
The NuVasive Reline Cervical 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 Reline Cervical 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 Reline Cervical System may be connected to the NuVasive SpheRx Spinal System, Precept Spinal System, Armada Spinal System, Reline System and Reline 4.5-5.0 System via the rod to rod connectors or transition rods.

Source page: https://510kreport.com/device/K213654
Methodology: https://510kreport.com/methodology