# K122292: Reliance Posterior Cervical- Thoracic System

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Medical Systems, LLC
- Decided: Oct 24, 2012 after 85 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K853033 (1985). 22 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K092295: Pioneer Posterior Cervico-Thoracic System, Pioneer Surgical Technology (2010) Summary page 1.
- K083073: Theken Atoll Cervico-Thoracic System, Theken Spine, LLC (2009) Summary page 1.
- K052201: Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2005) Summary page 1.

## Most influential descendants
- K142867: Reliance Posterior Cervical-Thoracic System (2015), 3 descendants of its own
- K213394: Vy Spine™ VySpan™ PCT System (2021), 2 descendants of its own
- K223852: VySpan™ PCT System (2023), 1 descendant of its own
- K232167: VySpan™ PCT System (2023), 0 descendants of its own

## Indications for use
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C I-T3), and is indicated for the following: * ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * spondylolisthesis * spinal stenosis * fracture/dislocation * revision of previous cervical spine surgery *tumors The use of the mini polyaxial screws is limited to placement in the upper thoracic spine JTI - T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Hooks and Rods The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dis location or trauma in the cervical/upper thoracic (C]-T3) spine. WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine. Pedicle screws are intended for placement only in TI-T3 as a means of anchoring the system.

Source page: https://510kreport.com/device/K122292
Methodology: https://510kreport.com/methodology