# K070245: Capsure Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Apr 5, 2007 after 70 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: 4 generations back to K951116 (1995). 21 ancestors in all.
42 later devices descend from it; 3 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)
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 2.
- K043522: Issys Pedicle Screw System, Custom Spine, Inc. (2005) Summary page 2.
- K041925: ST360 Spinal Fixation System, Zimmer Spine, Inc. (2004) Summary page 2.

## Most influential descendants
- K081228: Capsure PS (R) Spine System (2008), 39 descendants of its own
- K083353: Capsure (R) PS System (2008), 36 descendants of its own
- K100605: Mis System (2010), 33 descendants of its own
- 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

## Indications for use
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure TM 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 TM 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/K070245
Methodology: https://510kreport.com/methodology