# K142655: CB PROT II Posterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Chin Bone Technique Corp
- Decided: Jan 26, 2015 after 130 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 7 generations back to K901587 (1990). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111883: Smartloc Spinal Fixation System, A-Spine Asia, Co., Ltd. (2011) Summary page 4.

## Indications for use
The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, non-cervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications: - Trauma (i.e. fracture or dislocation). - Spinal stenosis. - Vertebral tumors. - Pseudoarthrosis and failed previous fusion in skeletally mature patients. - Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra. The system is intended to be used with autograft or allograft to facilitate fusion.

Source page: https://510kreport.com/device/K142655
Methodology: https://510kreport.com/methodology