# K100605: Mis System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jun 4, 2010 after 93 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 K951116 (1995). 30 ancestors in all.
33 later devices descend from it; 4 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081228: Capsure PS (R) Spine System, Spine Wave, Inc. (2008) Summary page 2.
- K083353: Capsure (R) PS System, Spine Wave, Inc. (2008) Summary page 2.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 2.
- K071860: Modification to: Viper Spine System, Depuy Spine, Inc. (2007) Summary page 2.
- K032033: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- K032265: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.

## Most influential descendants
- K111115: Captiva Spine Caplox II Spinal Fixation System (2011), 16 descendants of its own
- K120292: Caplox II Pedicle Screw System (2012), 15 descendants of its own
- K122332: Towerlox Pedicle Screw System (2012), 14 descendants of its own
- K151813: Sniper Spine System (2015), 9 descendants of its own
- K152174: Sniper Spine System (2015), 8 descendants of its own

## Indications for use
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MIS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The MIS Pedicle Screw System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L-5-S I vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S 1), and for whom the device is intended to be removed after solid fusion is attained. The Spine Wave MIS Percutaneous Instruments are intended to be used with the MIS Pedicle Screw System [mplants. The percutaneous instruments when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). As well as, for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-SlI vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S 1), and for whom the device is intended to be removed after solid fusion is attained.

Source page: https://510kreport.com/device/K100605
Methodology: https://510kreport.com/methodology