# K122233: Capsure (R) PS System

- Pathway: 510(k) (Special)
- Applicant: Spine Wave, Inc.
- Decided: Oct 11, 2012 after 77 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
No predicates in its family tree.
12 later devices descend from it; 1 cites 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)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K104: CapSure® PS System. Number could not be read Summary page 1.

## Most influential descendants
- K132154: Capsure PS System (2013), 11 descendants of its own
- 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

## 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/K122233
Methodology: https://510kreport.com/methodology