# K083743: Capsure PS System

- Pathway: 510(k) (Special)
- Applicant: Spine Wave, Inc.
- Decided: Jan 13, 2009 after 28 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: 7 generations back to K951116 (1995). 27 ancestors in all.
3 later devices descend from it; 3 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)
- K083353: Capsure (R) PS System, Spine Wave, Inc. (2008) Summary page 2.
- K052847: Capless Pedicle Screw System, X-Spine Systems, Inc. (2005) Summary page 2.
- K070300: Expedium SFX Cross Connector System, Depuy Spine, Inc. (2007) Summary page 2.

## Most influential descendants
- K100122: Modification to Capsure PS System (2010), 2 descendants of its own
- 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-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.

Source page: https://510kreport.com/device/K083743
Methodology: https://510kreport.com/methodology