510(k) · Cleared
ClearedLife Spine SIMPACT Sacroiliac Joint Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Jun 15, 2018 as substantially equivalent to K141246 (Life Spine, Inc., 2015) after an 85-day review. Its family tree reaches back 7 generations to 1990. 14 later devices descend from it.
- Decided
- Jun 15, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K903810 (1990). 12 ancestors in all. 14 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 backK141246 Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2015
- This deviceK180749 Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2018
- Descendant · cites it directly · 13 of its ownK201538 Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2020
- Descendant · cites it directly · 8 of its ownK212903 SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
- Descendant · 2 generations on · 2 of its ownK223819 SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC · 2023
- Descendant · cites it directly · 1 of its ownK241464 ARx® SAI Implant SystemLife Spine, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2020 · cites it directly13descendants
- K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2021 · cites it directly8descendants
- K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023 · 2 generations on3descendants
- K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC · 2023 · 2 generations on2descendants
- K241464ARx® SAI Implant SystemLife Spine, Inc. · 2024 · cites it directly1descendant
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 | K141246 | Life Spine Sacroiliac Joint Fixation System | Life Spine, Inc. | 2015 | — |
| 0 (this device) | K180749 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2018 | — |
| +1 | K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2020 | — |
| +1 | K212903 | SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2021 | — |
| +2 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023 | — |
| +2 | K223819 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | 2023 | — |
| +1 | K241464 | ARx® SAI Implant System | Life Spine, Inc. | 2024 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K141246 | Life Spine Sacroiliac Joint Fixation SystemSummary page 4…HWC, CFR 888.3040 Smooth or threaded metallic bone fixation fastener, Class II Primary Predicate: Life Spine Sacroiliac Joint Fixation System (K141246) Device Description: The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially… | 2015 |
What descends from it? (14)
See all 144 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 28 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K201538 (Life Spine, Inc., 2020) has gone furthest, with 13 descendants of its own.
- 6 other devices also cite its predicate K141246.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Life Spine SIMPACT Sacroiliac Joint Fixation 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/K180749 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180749: Life Spine SIMPACT Sacroiliac Joint Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180749
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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