510(k) · Cleared
ClearedSacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lesspine Innovations · OUR Sacroiliac Joint Fixation
Cleared on Sep 28, 2023 as substantially equivalent to K150017 (Spinefrontier, Inc., 2015) and 10 other predicates after a 31-day review. Its family tree reaches back 22 generations to 1993.
- Decided
- Sep 28, 2023
- Review
- 31 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 22 generations to K930834 (1993). 329 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 22 generations backK930834 AcutractAcu Med, Inc. · 1993
- 18 generations between
- 3 generations backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- 2 generations backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- 1 generation backK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
- This deviceK232605 Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES…Lesspine Innovations · 2023
Show all 22 generations
- Root · 22 generations backK930834 AcutractAcu Med, Inc. · 1993
- 21 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 20 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 19 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 18 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 17 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 16 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 15 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 14 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 13 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 12 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 11 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 10 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 9 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 8 generations backK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- 7 generations backK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- 6 generations backK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 5 generations backK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 4 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 3 generations backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- 2 generations backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- 1 generation backK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
- This deviceK232605 Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES…Lesspine Innovations · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −21 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −20 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −19 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −18 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −17 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −16 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −15 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −14 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −13 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −12 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −11 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −10 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −9 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −8 | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| −7 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| −6 | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −5 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −4 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
| −3 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| −2 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| −1 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023 | — |
| 0 (this device) | K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System… | Lesspine Innovations | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 9 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 13 | 0 |
| 1996 | 5 | 0 |
| 1997 | 14 | 0 |
| 1998 | 11 | 0 |
| 1999 | 11 | 0 |
| 2000 | 17 | 0 |
| 2001 | 16 | 0 |
| 2002 | 15 | 0 |
| 2003 | 18 | 0 |
| 2004 | 23 | 0 |
| 2005 | 23 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 13 | 0 |
| 2009 | 4 | 0 |
| 2010 | 11 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 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? (11)
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 |
|---|---|---|---|
| * | K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSummary page 8…acrix® Sacroiliac Joint Fusion System Device Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate Type K150017 Sacrix® Sacroiliac Joint Fusion Device System LESspine Innovations Primary K021932 Synthes 6.5 mm Cannul… | 2015 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 8…odel Name Manufacturer Predicate Type K150017 Sacrix® Sacroiliac Joint Fusion Device System LESspine Innovations Primary K021932 Synthes 6.5 mm Cannulated Screw Synthes (USA) Additional K223708 Entasis 3D Dual-Le… | 2002 |
| * | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant SystemSummary page 8…c Joint Fusion Device System LESspine Innovations Primary K021932 Synthes 6.5 mm Cannulated Screw Synthes (USA) Additional K223708 Entasis 3D Dual-Lead Sacroiliac Implant System CoreLink, LLC Additional Inspan® ScrewLES Fusion System Pr… | 2023 |
| * | K213266 | Inspan ScrewLES Fusion SystemSummary page 8…Additional Inspan® ScrewLES Fusion System Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate Type K213266 InSpan ScrewLES Fusion System LESspine Innovations Primary Invue® MAX™ + Invue Inset Anterior C… | 2021 |
| * | K121060 | Spine Frontier Indus Acp SystemSummary page 8…+ Invue Inset Anterior Cervical Plate System Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate Type K121060 SpineFrontier Indus™ LESspine Innovation Primary K093776 Indus™ Anterior Cervical… | 2012 |
| * | K093776 | Indus Anterior Cervical Plate SystemSummary page 8…Model Name Manufacturer Predicate Type K121060 SpineFrontier Indus™ LESspine Innovation Primary K093776 Indus™ Anterior Cervical Plate System LESspine Innovation Additional K163104 Terrace™ Anterior Cer… | 2010 |
| * | K163104 | Terrace™ Anterior Cervical Plate SystemSummary page 8…LESspine Innovation Primary K093776 Indus™ Anterior Cervical Plate System LESspine Innovation Additional K163104 Terrace™ Anterior Cervical Plate System CoreLink, LLC Additional FacetFuse® Screw Fixation System… | 2017 |
| * | K071420 | Chameleon Fixation SystemSummary page 8…dditional FacetFuse® Screw Fixation System Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate Type K071420 Chameleon FacetFuse MIS Screw System LESspine Innovation Primary K211855 Ion Facet Screw System… | 2008 |
| * | K211855 | Ion Facet Screw SystemSummary page 8…odel Name Manufacturer Predicate Type K071420 Chameleon FacetFuse MIS Screw System LESspine Innovation Primary K211855 Ion Facet Screw System SurGenTec, LLC Additional K131471 Facet Fixx™… | 2022 |
| * | K131471 | Self-Compressive ScrewSummary page 8…e MIS Screw System LESspine Innovation Primary K211855 Ion Facet Screw System SurGenTec, LLC Additional K131471 Facet Fixx™ Nexxt Spine Additional K012773 Discovery Facet Scr… | 2013 |
| * | K012773 | Discovery Facet Screw Fixation SystemSummary page 8…m SurGenTec, LLC Additional K131471 Facet Fixx™ Nexxt Spine Additional K012773 Discovery Facet Screw Fixation System DePuy AcroMed™, Inc. Additional PERFORMANCE DATA The Sacrix® Sa… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 companies; a new generation was cleared every 7 months on median.
- 40 of the 329 ancestors have a recall of any class.
- 3 other devices also cite its predicate K150017.
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 Sacrix® Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The InSpan® ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the…
Read the full statement (342 words)
The Sacrix® Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The InSpan® ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.
The Invue® MAX™ + Invue Inset Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma; (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudloarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.
The FacetFuse® Screw Fixation System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1) Trauma, including spinal fractures and/ or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232605: Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw 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/K232605
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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