510(k) · Cleared
ClearedAscend Spinal Fixation System with the Shadow Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Innovations, LLC · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 30, 2002 after a 127-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jan 30, 2002
- Review
- 127 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK013196 Ascend Spinal Fixation System with the Shadow Spinal SystemSpinal Innovations, LLC · 2002
- Descendant · cites it directly · 2 of its ownK142939 Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2015
- Descendant · cites it directly · 1 of its ownK160216 Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2016
- Descendant · cites it directly · 0 of its ownK163056 Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC · 2017
- Descendant · cites it directly · 0 of its ownK083004 Mili (Minimally Invasive Lumbar Implant) SystemAesculap Implant Systems, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K142939Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2015 · cites it directly2descendants
- K160216Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2016 · cites it directly1descendant
- K163056Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC · 2017 · cites it directly0descendants
- K083004Mili (Minimally Invasive Lumbar Implant) SystemAesculap Implant Systems, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013196 | Ascend Spinal Fixation System with the Shadow Spinal System | Spinal Innovations, LLC | 2002 | — |
| +1 | K142939 | Revolution Spinal Fixation System | Intelligent Implant Systems, LLC | 2015 | — |
| +1 | K160216 | Revolution Spinal Fixation System | Intelligent Implant Systems, LLC | 2016 | — |
| +1 | K163056 | Revolution™ Spinal Fixation System | Intelligent Implant Systems, LLC | 2017 | — |
| +1 | K083004 | Mili (Minimally Invasive Lumbar Implant) System | Aesculap Implant Systems, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Spinal Innovations Ascend™ Spinal Fixation System Named without a submission number | |
| * | — | Sulzer Spine-Tech Silhouette™ Spinal System Named without a submission number |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142939 (Intelligent Implant Systems, LLC, 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.…
Read the full statement (325 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013196: Ascend Spinal Fixation System with the Shadow Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013196
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026