510(k) · Cleared
ClearedSimmetry (TM) 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 Jul 21, 2011 as substantially equivalent to K110512 (Zyga Technology, Inc., 2011) after a 24-day review. Its family tree reaches back 4 generations to 1990. 1 of the 249 devices in its family, counting itself, has a Class I recall. 240 later devices descend from it.
- Decided
- Jul 21, 2011
- Review
- 24 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K903810 (1990). 8 ancestors in all. 240 later devices descend from it, 3 citing it directly. 1 of the 249 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 3 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 2 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- 1 generation backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- This deviceK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- Descendant · cites it directly · 238 of its ownK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
- Descendant · cites it directly · 92 of its ownK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
- Descendant · cites it directly · 85 of its ownK130092 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2013
- Descendant · 2 generations on · 84 of its ownK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- Descendant · 3 generations on · 83 of its ownK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
Showing 5 of 240 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 240 · See all- K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011 · cites it directly238descendants
- K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012 · cites it directly92descendants
- K130092Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2013 · cites it directly85descendants
- K152681iFuse Implant System (R)SI-BONE, Inc. · 2016 · 2 generations on84descendants
- K160652iFUSE Implant SystemSI-BONE, Inc. · 2016 · 3 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −3 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −2 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| −1 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| 0 (this device) | K111801 | Simmetry (TM) Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| +1 | K112028 | SI-Lok Sacroiliac Joint Fixation System | Globus Medical, Inc. | 2011 | — |
| +1 | K110472 | SI-Fix Sacroiliac Joint Fusion System | Medtronic Sofamor Danek | 2012 | — |
| +1 | K130092 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2013 | — |
| +2 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| +3 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 18 | 1 |
| 2022 | 24 | 0 |
| 2023 | 40 | 0 |
| 2024 | 37 | 0 |
| 2025 | 36 | 0 |
| 2026 | 38 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K110512 | Simmetry Sacroiliac Joint Fusion SystemSummary page 2…and material Conclsioncomposition and mechanical performance when compared to the predicate device cleared under ________________ K110512. Paget 7-4 DEPARTM… | 2011 |
What descends from it? (240)
See all 2403 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K112028 (Globus Medical, Inc., 2011) has gone furthest, with 238 descendants of its own.
- 1 other device also cites its predicate K110512.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Slmmetry TM Sacroiliac 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/K111801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111801: Simmetry (TM) 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/K111801
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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