510(k) · Cleared
ClearedSI-Technology® SI-Desis® Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Si-Technology, LLC · OUR Sacroiliac Joint Fixation
Cleared on Aug 12, 2015 as substantially equivalent to K112028 (Globus Medical, Inc., 2011) and 1 other predicate after a 72-day review. Its family tree reaches back 6 generations to 1990. 5 later devices descend from it.
- Decided
- Aug 12, 2015
- Review
- 72 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K903810 (1990). 11 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 5 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 4 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- 3 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 2 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 1 generation backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
- This deviceK151462 SI-Technology® SI-Desis® ScrewsSi-Technology, LLC · 2015
- Descendant · cites it directly · 2 of its ownK210402 Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK243565 DYNAMIS™ SI Screw SystemPromethean Restorative, LLC · 2025
- Descendant · cites it directly · 1 of its ownK241813 SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK251525 SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK251075 DYNAMIS™ Implant SystemPromethean Restorative, LLC · 2025
Most influential descendants
Showing 5 of 5 · See all- K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc. · 2021 · cites it directly2descendants
- K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC · 2025 · 2 generations on1descendant
- K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC · 2024 · cites it directly1descendant
- K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC · 2025 · 2 generations on0descendants
- K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −5 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −4 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| −3 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −2 | K111801 | Simmetry (TM) Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −1 | K112028 | SI-Lok Sacroiliac Joint Fixation System | Globus Medical, Inc. | 2011 | — |
| 0 (this device) | K151462 | SI-Technology® SI-Desis® Screws | Si-Technology, LLC | 2015 | — |
| +1 | K210402 | Curiteva Sacroiliac Joint Fusion System | Curiteva, Inc. | 2021 | — |
| +2 | K243565 | DYNAMIS™ SI Screw System | Promethean Restorative, LLC | 2025 | — |
| +1 | K241813 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | 2024 | — |
| +2 | K251525 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | 2025 | — |
| +3 | K251075 | DYNAMIS™ Implant System | Promethean Restorative, LLC | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K112028 | SI-Lok Sacroiliac Joint Fixation SystemSummary page 4…eaded metallic bone fixation fastener Code –Classification OUR, HWC 21 CFR 888.3040 : Class II Predicate Devices K112028 – Globus SI-LOK Sacroiliac Joint Fixation System K021932 - Synthes 6.5 mm Cannulated Screw… | 2011 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 4…21 CFR 888.3040 : Class II Predicate Devices K112028 – Globus SI-LOK Sacroiliac Joint Fixation System K021932 - Synthes 6.5 mm Cannulated Screw Device Description The SI-TECHNOLOGY® SI-DESIS® Sacroiliac Joint Fusion Screw Syst… | 2002 |
What descends from it? (5)
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 25 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K210402 (Curiteva, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 15 other devices also cite its predicate K112028.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 SI-TECHNOLOGY Device is intended for sacroiliac joint fusion for conditions including sacroiliac (SI) joint disruptions and degenerative sacroiliitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151462: SI-Technology® SI-Desis® Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151462
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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