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 Dec 14, 2010 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 2 other predicates after a 74-day review. Its family tree reaches back 2 generations to 1990. 1 of the 252 devices in its family, counting itself, has a Class I recall. 245 later devices descend from it.
- Decided
- Dec 14, 2010
- Review
- 74 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K903810 (1990). 6 ancestors in all. 245 later devices descend from it, 3 citing it directly. 1 of the 252 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 1 generation backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- This deviceK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- Descendant · cites it directly · 241 of its ownK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- Descendant · 2 generations on · 240 of its ownK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- Descendant · 2 generations on · 238 of its ownK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
- Descendant · 3 generations on · 92 of its ownK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
- Descendant · 3 generations on · 85 of its ownK130092 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2013
Showing 5 of 245 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 245 · See all- K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · cites it directly241descendants
- K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 2 generations on240descendants
- K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011 · 2 generations on238descendants
- K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012 · 3 generations on92descendants
- K130092Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2013 · 3 generations on85descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −1 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| 0 (this device) | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| +1 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| +2 | K111801 | Simmetry (TM) Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| +2 | K112028 | SI-Lok Sacroiliac Joint Fixation System | Globus Medical, Inc. | 2011 | — |
| +3 | K110472 | SI-Fix Sacroiliac Joint Fusion System | Medtronic Sofamor Danek | 2012 | — |
| +3 | K130092 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2013 | — |
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 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 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 30.8 · 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? (3)
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 |
|---|---|---|---|
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 1…fixation fastener : Classification Qlass II (per 21 CFR § 888.3040) Zyga Technology, Inc. ; Manufacturer 700 10th Ave South, Suite 400 ' . Minneapolis, MN 55415-1745 o K021932 : ‘ Synthes (USA) ! Synthes 6.5mm Cannulated Screw ! SIJF Cannulated Screw System o K092375 ! SI-Bane, Inc. ! Sk Jcint Fuston S… | 2002 |
| * | K051296 | Sijf Cannulated Screw SystemSummary page 2…ial composition and mechanical performance when compared to the predicate devices deared under the following submissions: ¢ K021932 Synthes 6.5mm Cannulated Screw o K051296 DePuy 6.5mm and 8.0mm SDF Cannulated Screw System o K092375 SI Joint Fusion System '| conclusion Pagé? ch 2. A… | 2005 |
| * | K092375 | Modification to SI Joint Fusion SystemSummary page 1…anufacturer 700 10th Ave South, Suite 400 ' . Minneapolis, MN 55415-1745 o K021932 : ‘ Synthes (USA) ! Synthes 6.5mm Cannulated Screw ! SIJF Cannulated Screw System o K092375 ! SI-Bane, Inc. ! Sk Jcint Fuston System The SImmetry Sacroiliac Joint Fusion System consists . . of cannulated screws available… | 2009 |
What descends from it? (245)
See all 2453 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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K110512 (Zyga Technology, Inc., 2011) has gone furthest, with 241 descendants of its own.
- 61 other devices also cite its predicate K021932.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
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/K102907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102907: Simmetry Sacroiliac Joint Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102907
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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