# K152211: PCT System

- Pathway: 510(k) (Traditional)
- Applicant: Centinel Spine, Inc.
- Decided: Dec 1, 2015 after 116 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: 15 generations back to K003155 (2001). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.
- K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System, Pioneer Surgical Technology, Inc. (2012) Summary page 4.
- K030197: Blackstone Posterior Cervical System, Blackstone Medical, Inc. (2003) Summary page 4.
- K140645: Gibralt Rod-to-Rod Cross Connectors, Exactech Sarasota (2014) Summary page 4.
- K110197: Exactech Gibralt Spinal System, Exactech, Inc. (2011) Summary page 4.

## Indications for use
The CENTINEL SPINE PCT 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 cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); 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 CENTINEL SPINE PCT 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.

Source page: https://510kreport.com/device/K152211
Methodology: https://510kreport.com/methodology