510(k) · Cleared
ClearedEVOL® -SI Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutting Edge Spine, LLC · OUR Sacroiliac Joint Fixation
Cleared on Aug 12, 2019 as substantially equivalent to K171595 (Medacta International S.A., 2017) and 1 other predicate after a 217-day review. Its family tree reaches back 7 generations to 1990. 6 later devices descend from it.
- Decided
- Aug 12, 2019
- Review
- 217 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K903810 (1990). 13 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 6 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 5 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- 4 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 3 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 2 generations backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
- 1 generation backK171595 M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A. · 2017
- This deviceK190025 EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC · 2019
- Descendant · cites it directly · 3 of its ownK213030 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK214123 T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK252205 Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK…Curiteva, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK254061 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240250 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023 · cites it directly3descendants
- K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC · 2022 · cites it directly1descendant
- K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc. · 2026 · 2 generations on0descendants
- K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2026 · 2 generations on0descendants
- K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −6 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −5 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| −4 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −3 | K111801 | Simmetry (TM) Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −2 | K112028 | SI-Lok Sacroiliac Joint Fixation System | Globus Medical, Inc. | 2011 | — |
| −1 | K171595 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System | Medacta International S.A. | 2017 | — |
| 0 (this device) | K190025 | EVOL® -SI Joint Fusion System | Cutting Edge Spine, LLC | 2019 | — |
| +1 | K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2023 | — |
| +1 | K214123 | T-FIX® 3DSI Joint Fusion System | Cutting Edge Spine, LLC | 2022 | — |
| +2 | K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar… | Curiteva, Inc. | 2026 | — |
| +2 | K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026 | — |
| +2 | K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 OUR? 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 OUR device
- #1 K233508 iFuse Bedrock Granite® Implant Systemscore 30.7 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K171595 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemSummary page 5…er Device Manufacturer Primary M.U.S.T. Sacral Iliac Medacta K171595 Predicate Screws International Additional… | 2017 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 5…dicate Screws International Additional Synthes 6.5 mm K021932 Depuy Synthes Predicate Cannulated Screw… | 2002 |
| † | K150321 | EVOS Lumbar Interbody System | 2015 |
| † | K101225 | Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant… | 2011 |
What descends from it? (6)
2 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?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K213030 (Curiteva, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K171595.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OUR
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OUR
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OUR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUR
10in 2025
MAUDE reports naming product code OUR, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 27 | 0 | 6 |
| 2012 | 2 | — | 0 | 81 |
| 2013 | 4 | 103 | 0 | 96 |
| 2014 | 3 | 91 | 0 | 146 |
| 2015 | 8 | 111 | 0 | 119 |
| 2016 | 6 | 168 | 0 | 122 |
| 2017 | 4 | 120 | 0 | 157 |
| 2018 | 7 | 82 | 0 | 137 |
| 2019 | 7 | 89 | 0 | 175 |
| 2020 | 7 | 88 | 0 | 148 |
| 2021 | 9 | 85 | 0 | 154 |
| 2022 | 14 | 149 | 0 | 23 |
| 2023 | 20 | 55 | 0 | 7 |
| 2024 | 15 | 74 | 0 | 15 |
| 2025 | 14 | 97 | 1 | 10 |
| 2026 | 6 | 98 | 1 | — |
What is it indicated for?
The EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190025: EVOL® -SI Joint Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190025
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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