# K131522: Core Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Core-Nexus
- Decided: Aug 9, 2013 after 73 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 6 generations back to K000319 (2000). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113324: Rexious Hook Fixation Systems, Dio Medical Co., Ltd. (2012) Summary page 1.
- K111362: Rexious Spinal Fixation System, Dio Medical Co., Ltd. (2011) Summary page 1.
- K100765: Fixpine II System, Dio Medical Co., Ltd. (2010) Summary page 1.

## Indications for use
The Care Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spandylolisthesis (Grade 3 and 4) at the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal at the implants after the attainment af a solid fusion. In addition, the Core Pedicle Screw 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 or deformities at the thoracic lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosls). The Core Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion. The Care Hook System can be used in conjunction with Core Pedicle Screw System.

Source page: https://510kreport.com/device/K131522
Methodology: https://510kreport.com/methodology