# K160020: Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Captiva Spine
- Decided: Mar 2, 2016 after 57 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: 16 generations back to K853033 (1985). 209 ancestors in all.
No later device cites it as a predicate yet.
0 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151116: CapLOX II/TowerLOX Pedicle Screw System, Captiva Spine (2015) Summary page 6.

## Indications for use
The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudloarthrosis and failed previous fusion. When used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), or who are having the device removed after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K160020
Methodology: https://510kreport.com/methodology