# K120292: Caplox II Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Captiva Spine, Inc.
- Decided: Apr 13, 2012 after 73 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K951116 (1995). 51 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111115: Captiva Spine Caplox II Spinal Fixation System, Captiva Spine, Inc. (2011)

## Most influential descendants
- K122332: Towerlox Pedicle Screw System (2012), 14 descendants of its own
- K131538: Caplox II Pedicle Screw System/Towerlox Pedicle Screw System (2013), 6 descendants of its own
- K152781: Adena-Zina System (2016), 5 descendants of its own
- K212066: Adena-Zina System (2021), 3 descendants of its own
- K151116: CapLOX II/TowerLOX Pedicle Screw System (2015), 3 descendants of its own

## Recalls of this device
- Sep 20, 2012 · Class II · Z-0413-2013: Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking

## Indications for use
The CapLOX II Spinal 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, pseudoarthrosis and failed previous fusion. In addition, when used as a pedicle screw fixation system, the CapLOX II Spinal 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), who are having the device removed after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K120292
Methodology: https://510kreport.com/methodology