# K211993: Z-LINKPC System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Aug 11, 2021 after 44 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: 19 generations back to K040583 (2004). 331 ancestors in all.
No later device cites it as a predicate yet.
1 of 332 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180198: NuVasive® VuePoint® II OCT System, Nu Vasive, Incorporated (2018) Summary page 5.
- K180025: Centurion POCT System, Orthofix, Inc. (2018) Summary page 5.

## Indications for use
The Z-LINKPC System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-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/thoracic 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. These implants are 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. To achieve additional levels of fixation, the Z-LINKPC System may be connected to the Zavation Spinal System using rod connectors and tapered rods. When used with the occipital plate, the Z-LINKPC System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic juction (occiput-T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.

Source page: https://510kreport.com/device/K211993
Methodology: https://510kreport.com/methodology