# K120646: Capsure (R) PS System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jun 7, 2012 after 97 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: 10 generations back to K951116 (1995). 82 ancestors in all.
No later device cites it as a predicate yet.
1 of 83 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070245: Capsure Pedicle Screw System, Spine Wave, Inc. (2007) Summary page 1.
- K081228: Capsure PS (R) Spine System, Spine Wave, Inc. (2008) Summary page 1.
- K083353: Capsure (R) PS System, Spine Wave, Inc. (2008) Summary page 1.
- K083743: Capsure PS System, Spine Wave, Inc. (2009) Summary page 1.
- K100122: Modification to Capsure PS System, Spine Wave, Inc. (2010) Summary page 1.
- K111913: Capsure (R) PS System, Spine Wave, Inc. (2011)
- K083393: Xia 3 Spinal System, Stryker Spine (2009) Summary page 1.
- K111358: Synthes Uss, Synthes Spine (2011) Summary page 1.

## Indications for use
The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) 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-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.

Source page: https://510kreport.com/device/K120646
Methodology: https://510kreport.com/methodology