# K160003: Sniper (R) Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Feb 26, 2016 after 53 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). 35 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152174: Sniper Spine System, Spine Wave, Inc. (2015) Summary page 5.
- K132154: Capsure PS System, Spine Wave, Inc. (2013) Summary page 5.

## Most influential descendants
- 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
- K240685: Salvo® Spine System (2024), 2 descendants of its own

## Indications for use
The Sniper® Spine System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The Sniper® Spine System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Sniper® Spine 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. The Sniper® Spine System percutaneous instruments are intended to be used with the Sniper® System Implants. The instruments, when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The instruments are also intended to provide a percutaneous approach 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 L.3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.

Source page: https://510kreport.com/device/K160003
Methodology: https://510kreport.com/methodology