# K132154: Capsure PS System

- Pathway: 510(k) (Special)
- Applicant: Spine Wave, Inc.
- Decided: Aug 9, 2013 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: 1 generation back to K122233 (2012). 1 ancestor in all.
11 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122233: Capsure (R) PS System, Spine Wave, Inc. (2012) Summary page 4.

## Most influential descendants
- K160003: Sniper (R) Spine System (2016), 7 descendants of its own
- K182954: Salvo™ Spine System (2018), 6 descendants of its own
- K191045: Salvo™ Spine System (2019), 5 descendants of its own
- K202476: Salvo® Spine System (2020), 4 descendants of its own
- K222362: Salvo® Spine System (2022), 3 descendants of its own

## 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/K132154
Methodology: https://510kreport.com/methodology