# K162639: Proficient™ Posterior Cervical Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Feb 7, 2017 after 138 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: 3 generations back to K953076 (1997). 4 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 18 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.

## Most influential descendants
- K172594: Proficient® Posterior Cervical Spine System (2017), 12 descendants of its own
- K182954: Salvo™ Spine System (2018), 6 descendants of its own
- K191045: Salvo™ Spine System (2019), 5 descendants of its own
- K202476: Salvo® Spine System (2020), 4 descendants of its own
- K181440: Proficient® Posterior Cervical Spine System (2018), 4 descendants of its own

## Indications for use
The Proficient™ Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C2-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, 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 Proficient™ Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient™ Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient™ transition rods.

Source page: https://510kreport.com/device/K162639
Methodology: https://510kreport.com/methodology