# K013196: Ascend Spinal Fixation System with the Shadow Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Innovations, LLC
- Decided: Jan 30, 2002 after 127 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Spinal Innovations Ascend™ Spinal Fixation System: named in the summary without a submission number
- (no number) Sulzer Spine-Tech Silhouette™ Spinal System: named in the summary without a submission number

## Most influential descendants
- K142939: Revolution Spinal Fixation System (2015), 2 descendants of its own
- K160216: Revolution Spinal Fixation System (2016), 1 descendant of its own
- K163056: Revolution™ Spinal Fixation System (2017), 0 descendants of its own
- K083004: Mili (Minimally Invasive Lumbar Implant) System (2009), 0 descendants of its own

## Indications for use
The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint; b) who are receiving fusion using autogenous graft only; ¢) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum. The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is a pedicle screw system intended to provide jmmobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations Ascend™ Spinal Fixation System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Source page: https://510kreport.com/device/K013196
Methodology: https://510kreport.com/methodology