# K100122: Modification to Capsure PS System

- Pathway: 510(k) (Special)
- Applicant: Spine Wave, Inc.
- Decided: Feb 12, 2010 after 28 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: 8 generations back to K951116 (1995). 28 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083743: Capsure PS System, Spine Wave, Inc. (2009) Summary page 2.
- K083353: Capsure (R) PS System, Spine Wave, Inc. (2008) Summary page 2.

## Most influential descendants
- K111913: Capsure (R) PS System (2011), 1 descendant of its own
- K120646: Capsure (R) PS System (2012), 0 descendants of its own

## Indications for use
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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-S1), and for whom the device is intended to be removed after solid fusion is attained.

Source page: https://510kreport.com/device/K100122
Methodology: https://510kreport.com/methodology