# K231811: Zavation Connector System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Aug 22, 2023 after 62 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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
Longest line of descent: 20 generations back to K040583 (2004). 311 ancestors in all.
No later device cites it as a predicate yet.
0 of 312 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170647: Connector System, Orthofix, Inc. (2017) Summary page 5.
- K222614: Zavation Spinal System, Zavation Medical Products, LLC (2022) Summary page 5.
- K112484: Zavation Spinal System, Zavation, LLC (2011) Summary page 5.
- K162575: Z-LINKPC System, Zavation, LLC (2017) Summary page 5.

## Indications for use
When used with the Zavation ZLinkPC System for Posterior-Cervical-Thoracic (Occ-T3) The Zavation Connector System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of 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/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. When used with the Zavation Spinal System for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Illium) The Zavation Connector System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Illium) in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K231811
Methodology: https://510kreport.com/methodology