510(k) · Cleared
ClearedXenix Medical Sacroiliac Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ht Medical D.B.A. Xenix Medical · OUR Sacroiliac Joint Fixation
Cleared on Aug 15, 2023 as substantially equivalent to K222605 (SI-BONE, Inc., 2022) and 3 other predicates after a 55-day review. Its family tree reaches back 21 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 15, 2023
- Review
- 55 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K930834 (1993). 150 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 21 generations backK930834 AcutractAcu Med, Inc. · 1993
- 17 generations between
- 3 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 2 generations backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- 1 generation backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- This deviceK231829 Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 2023
- Descendant · cites it directly · 1 of its ownK233241 SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical · 2023
- Descendant · 2 generations on · 0 of its ownK262193 RIVA® Posterior Fixation System with NanoACTIV Surface Technology…Xenix Medical · 2026
Show all 21 generations
- Root · 21 generations backK930834 AcutractAcu Med, Inc. · 1993
- 20 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 19 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 18 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 17 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 16 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 15 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 14 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 13 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 12 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 11 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 10 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 9 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 8 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 7 generations backK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- 6 generations backK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- 5 generations backK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 4 generations backK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 3 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 2 generations backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- 1 generation backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- This deviceK231829 Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −20 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −19 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −18 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −17 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −16 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −15 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −14 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −13 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −12 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −11 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −10 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −9 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −8 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −7 | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| −6 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| −5 | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −4 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −3 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
| −2 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| −1 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| 0 (this device) | K231829 | Xenix Medical Sacroiliac Fixation System | Ht Medical D.B.A. Xenix Medical | 2023 | — |
| +1 | K233241 | SOLACE Sacroiliac Fixation System | Ht Medical, LLC Dba Xenix Medical | 2023 | — |
| +2 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA®… | Xenix Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K222605 | iFuse TORQ® Implant SystemSummary page 5…Manufacturer K-Number Primary Predicate Device iFuse TORQ Implant System SI-Bone K222605 Additional Predicate Devices RialtoTM SI Fusion System Medtronic K161210 Sa… | 2022 |
| * | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Summary page 5…SI-Bone K222605 Additional Predicate Devices RialtoTM SI Fusion System Medtronic K161210 Sacrix Sacroiliac Fixation SpineFrontier (Sacrix) K150017… | 2016 |
| * | K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSummary page 5…Medtronic K161210 Sacrix Sacroiliac Fixation SpineFrontier (Sacrix) K150017 (SacroFuse/SIJFuse) Synthes 6.5mm Cannulated Screw Synthes K021932 Referenc… | 2015 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 5…SpineFrontier (Sacrix) K150017 (SacroFuse/SIJFuse) Synthes 6.5mm Cannulated Screw Synthes K021932 Reference Device Quantum Anterior Cervical Plate (for Nvision Biomedical… | 2002 |
| † | K210424 | Quantum Anterior Cervical Plate | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233241 | SOLACE Sacroiliac Fixation System | 2023 | 1 |
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 30 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 21 of the 150 ancestors have a recall of any class.
- Of its descendants, K233241 (Ht Medical, LLC Dba Xenix Medical, 2023) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K222605.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for: • Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions • Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of…
Read the full statement (163 words)
The Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:
• Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion
The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The Xenix Medical Sacroiliac Fixation System Navigation Instruments are intended to be used with the Xenix Medical Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231829: Xenix Medical Sacroiliac 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/K231829
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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