510(k) · Cleared
ClearedPathLoc-SI Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · OUR Sacroiliac Joint Fixation
Cleared on Jul 16, 2018 as substantially equivalent to K153656 (L&K BIOMED Co., Ltd., 2016) after a 28-day review. Its family tree reaches back 8 generations to 1990. 11 later devices descend from it.
- Decided
- Jul 16, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K903810 (1990). 19 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 7 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 6 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- 5 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 4 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 3 generations backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
- 2 generations backK141246 Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2015
- 1 generation backK153656 PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2016
- This deviceK181600 PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2018
- Descendant · cites it directly · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- Descendant · 2 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK223521 ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · cites it directly10descendants
- K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 2 generations on6descendants
- K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · 2 generations on3descendants
- K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2023 · 2 generations on2descendants
- K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −7 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −6 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| −5 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −4 | K111801 | Simmetry (TM) Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −3 | K112028 | SI-Lok Sacroiliac Joint Fixation System | Globus Medical, Inc. | 2011 | — |
| −2 | K141246 | Life Spine Sacroiliac Joint Fixation System | Life Spine, Inc. | 2015 | — |
| −1 | K153656 | PathLoc-SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2016 | — |
| 0 (this device) | K181600 | PathLoc-SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2018 | — |
| +1 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| +2 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| +2 | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 2023 | — |
| +2 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023 | — |
| +2 | K223521 | ZESPIN SI Joint Fusion System | Aegis Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K153656 | PathLoc-SI Joint Fusion SystemSummary page 4…omponents of the PathLoc-SI Joint Fusion System 4. Predicate or legally marketed devices which are substantially equivalent Primary Predicate(unmodified device): K153656 PathLoc-SI Joint Fusion System 5. Description of the Device PathLoc-SI Joint Fusion System consists of different di… | 2016 |
What descends from it? (11)
See all 112 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 6 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K210035 (Aegis Spine, 2021) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K153656.
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 PathLoc-SI 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/K181600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181600: PathLoc-SI 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/K181600
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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