510(k) · Cleared
ClearedUNITY Sacroiliac Joint Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huvexel Co., Ltd. · OUR Sacroiliac Joint Fixation
Cleared on Apr 26, 2018 as substantially equivalent to K112028 (Globus Medical, Inc., 2011) and 2 other predicates after a 206-day review. Its family tree reaches back 6 generations to 1990. 3 later devices descend from it.
- Decided
- Apr 26, 2018
- Review
- 206 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K903810 (1990). 11 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 5 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 4 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- 3 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 2 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 1 generation backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
- This deviceK173201 UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK222448 UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK232877 FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex…K&J Consulting Corporation · 2023
- Descendant · 3 generations on · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
Most influential descendants
Showing 3 of 3 · See all- K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation · 2022 · cites it directly2descendants
- K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation · 2023 · 2 generations on1descendant
- K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −5 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −4 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| −3 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −2 | K111801 | Simmetry (TM) Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −1 | K112028 | SI-Lok Sacroiliac Joint Fixation System | Globus Medical, Inc. | 2011 | — |
| 0 (this device) | K173201 | UNITY Sacroiliac Joint Fixation System | Huvexel Co., Ltd. | 2018 | — |
| +1 | K222448 | UNITY Sacroiliac Joint Fixation System | Dio Medical Corporation | 2022 | — |
| +2 | K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex… | K&J Consulting Corporation | 2023 | — |
| +3 | K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K112028 | SI-Lok Sacroiliac Joint Fixation SystemSummary page 4…88.3040) Regulatory Class: II Product Code: OUR III PREDICATE DEVICE Primary Predicate: Globus Medical – SI-LOK Sacroiliac Joint Fixation System (K112028) Additional Predicates: Depuy-Synthes – Synthes Cannulated Screw System (K021932 & K962011) IV DEVICE DESCRIPTIO… | 2011 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 4…Primary Predicate: Globus Medical – SI-LOK Sacroiliac Joint Fixation System (K112028) Additional Predicates: Depuy-Synthes – Synthes Cannulated Screw System (K021932 & K962011) IV DEVICE DESCRIPTION The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhan… | 2002 |
| * | K962011 | Synthes 7.0/7.3 MM Cannulated ScrewsSummary page 4…dicate: Globus Medical – SI-LOK Sacroiliac Joint Fixation System (K112028) Additional Predicates: Depuy-Synthes – Synthes Cannulated Screw System (K021932 & K962011) IV DEVICE DESCRIPTION The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroil… | 1996 |
| † | K111362 | Rexious Spinal Fixation System | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222448 | UNITY Sacroiliac Joint Fixation System | 2022 | 2 |
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 5.3 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K222448 (Dio Medical Corporation, 2022) has gone furthest, with 2 descendants of its own.
- 15 other devices also cite its predicate K112028.
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 UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients 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/K173201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173201: UNITY Sacroiliac Joint Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173201
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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