510(k) · Cleared
ClearedRevolution Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Implant Systems, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 22, 2016 as substantially equivalent to K061364 (Life Spine, 2006) and 3 other predicates after an 84-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Apr 22, 2016
- Review
- 84 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K013196 (2002). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013196 Ascend Spinal Fixation System with the Shadow Spinal SystemSpinal Innovations, LLC · 2002
- 1 generation backK142939 Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2015
- This deviceK160216 Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2016
- Descendant · cites it directly · 0 of its ownK163056 Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K163056Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K160216 | Revolution Spinal Fixation System | Intelligent Implant Systems, LLC | 2016 | — |
| +1 | K163056 | Revolution™ Spinal Fixation System | Intelligent Implant Systems, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K061364 | Pilot Posterior Lumbar Plating SystemSummary page 4…CFR 888.3070) Regulatory Class: III Product Codes: MNI, MNH, NKB III. Predicate Devices Primary Predicate: LifeSpine PILOT®-P Posterior Lumbar Plating System (K061364) Additional Predicates: Intelligent Implant Systems: Revolution™ Spinal System (K142939) Medtronic Sofamor Danek: Dynalok Classi… | 2006 |
| * | K142939 | Revolution Spinal Fixation SystemSummary page 4…Devices Primary Predicate: LifeSpine PILOT®-P Posterior Lumbar Plating System (K061364) Additional Predicates: Intelligent Implant Systems: Revolution™ Spinal System (K142939) Medtronic Sofamor Danek: Dynalok Classic™ Spinal System (K023415) Spinal Innovations Ascend with Shadow Spinal Fixation System (… | 2015 |
| * | K023415 | Modification to Dynalok Classic Spinal SystemSummary page 4…lating System (K061364) Additional Predicates: Intelligent Implant Systems: Revolution™ Spinal System (K142939) Medtronic Sofamor Danek: Dynalok Classic™ Spinal System (K023415) Spinal Innovations Ascend with Shadow Spinal Fixation System (K013196)… | 2002 |
| * | K013196 | Ascend Spinal Fixation System with the Shadow Spinal SystemSummary page 4…tems: Revolution™ Spinal System (K142939) Medtronic Sofamor Danek: Dynalok Classic™ Spinal System (K023415) Spinal Innovations Ascend with Shadow Spinal Fixation System (K013196) K160216… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163056 | Revolution™ Spinal Fixation System | 2017 | 0 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 13.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K163056 (Intelligent Implant Systems, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061364.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the non-cervical, posterior spine in order to provide immobilization 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of…
Read the full statement (104 words)
The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the non-cervical, posterior spine in order to provide immobilization 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160216: Revolution Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160216
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026