510(k) · Cleared
ClearedSImmetry Sacroiliac Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zyga Technology, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Aug 5, 2015 as substantially equivalent to K141549 (Zyga Technology, Inc., 2015) after a 30-day review. Its family tree reaches back 7 generations to 1990. 42 later devices descend from it.
- Decided
- Aug 5, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K903810 (1990). 15 ancestors in all. 42 later devices descend from it, 4 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 backK141549 SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2015
- This deviceK151818 SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2015
- Descendant · cites it directly · 31 of its ownK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- Descendant · 2 generations on · 29 of its ownK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 26 of its ownK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- Descendant · 4 generations on · 25 of its ownK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- Descendant · 5 generations on · 19 of its ownK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019 · cites it directly31descendants
- K200696FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · 2 generations on29descendants
- K201664FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · 3 generations on26descendants
- K203138FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · 4 generations on25descendants
- K210667FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021 · 5 generations on19descendants
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 | K141549 | SImmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2015 | — |
| 0 (this device) | K151818 | SImmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2015 | — |
| +1 | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| +2 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| +3 | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| +4 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| +5 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | K141549 | SImmetry Sacroiliac Joint Fusion SystemSummary page 4…OUR Zyga Technology, Inc. Manufacturer 5600 Rowland Road, Suite 200 Minnetonka, MN 55343 Predicate Device K141549 SImmetry Sacroiliac Joint Fusion System The SImmetry Sacroiliac Joint Fusion System consists of… | 2015 |
What descends from it? (42)
See all 424 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 4 companies; a new generation was cleared every 7 months on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K183342 (Orthofix, Inc., 2019) has gone furthest, with 31 descendants of its own.
- 6 other devices also cite its predicate K141549.
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 SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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/K151818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151818: SImmetry Sacroiliac 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/K151818
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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