510(k) · Cleared
ClearedFrontier Devices Fusio Screw Fuze System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Folsom Metal Products, Inc. Dba Frontier Devices · OUR Sacroiliac Joint Fixation
Cleared on Oct 10, 2014 as substantially equivalent to K112028 (Globus Medical, Inc., 2011) and 1 other predicate after a 164-day review. Its family tree reaches back 6 generations to 1990. 3 later devices descend from it.
- Decided
- Oct 10, 2014
- Review
- 164 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K903810 (1990). 12 ancestors in all. 3 later devices descend from it, 1 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 deviceK141106 Frontier Devices Fusio Screw Fuze SystemFolsom Metal Products, Inc. Dba Frontier Devices · 2014
- Descendant · cites it directly · 2 of its ownK223819 SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK231951 SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK230226 Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023
Most influential descendants
Showing 3 of 3 · See allView 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) | K141106 | Frontier Devices Fusio Screw Fuze System | Folsom Metal Products, Inc. Dba Frontier Devices | 2014 | — |
| +1 | K223819 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | 2023 | — |
| +2 | K231951 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | 2023 | — |
| +3 | K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023 | — |
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 |
|---|---|---|
| 2023 | 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…Class II Product Code OUR Device Classification: Class II Predicate Devices: Globus Medical SI –Lok Sacroiliac Joint Fixation System (K112028) Silex Sacroiliac Joint Fusion System (K123702) Device Descriptions: Frontier Devices FUSIO Scre… | 2011 |
| * | K123702 | Silex Sacroiliac Joint Fusion SystemSummary page 4…Class II Predicate Devices: Globus Medical SI –Lok Sacroiliac Joint Fixation System (K112028) Silex Sacroiliac Joint Fusion System (K123702) Device Descriptions: Frontier Devices FUSIO Screw Fuze System The Frontier Devices FUSIO Screw… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223819 | SI-Cure Sacroiliac Joint Fusion System | 2023 | 2 |
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 24 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K223819 (Alevio, LLC, 2023) 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. 2014, 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 FUSIO Screw Fuze System is intended for large bone fixation, including 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/K141106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141106: Frontier Devices Fusio Screw Fuze System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141106
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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