# K111115: Captiva Spine Caplox II Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Captiva Spine, Inc.
- Decided: Sep 13, 2011 after 145 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: 8 generations back to K951116 (1995). 50 ancestors in all.
16 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)
- K100956: Spondy Spinal Fixation System, Allure Spine LLC (2010) Summary page 1.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- K100605: Mis System, Spine Wave, Inc. (2010) Summary page 1.

## Most influential descendants
- K120292: Caplox II Pedicle Screw System (2012), 15 descendants of its own
- 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

## Indications for use
The CapLOX 11Spinal 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 sacrat spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudloarthrosis and failed previous fusion. In addition, when used as a pedicle screw fixation system, the CapLOX 11Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, [S-Si 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 [3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K111115
Methodology: https://510kreport.com/methodology