510(k) · Cleared
ClearediGPS Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SI-BONE, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Sep 15, 2025 as substantially equivalent to K171651 (Globus Medical, Inc., 2017) and 1 other predicate after a 97-day review. Its family tree reaches back 21 generations to 2001. 1 of the 644 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 15, 2025
- Review
- 97 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K003155 (2001). 643 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 644 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations between
- 3 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 2 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- 1 generation backK220862 E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
- This deviceK251780 iGPS Navigation InstrumentsSI-BONE, Inc. · 2025
Show all 21 generations
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 20 generations backK012254 VBROsteotech, Inc. · 2001
- 19 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 18 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 16 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 11 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 9 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 7 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 6 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 5 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 4 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- 3 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 2 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- 1 generation backK220862 E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
- This deviceK251780 iGPS Navigation InstrumentsSI-BONE, Inc. · 2025
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −20 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −19 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −18 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −16 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −11 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −9 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −7 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −6 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −5 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −4 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| −3 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| −2 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| −1 | K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022 | — |
| 0 (this device) | K251780 | iGPS Navigation Instruments | SI-BONE, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 8 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 21 | 0 |
| 1996 | 19 | 0 |
| 1997 | 16 | 0 |
| 1998 | 28 | 0 |
| 1999 | 20 | 0 |
| 2000 | 40 | 0 |
| 2001 | 41 | 0 |
| 2002 | 35 | 0 |
| 2003 | 32 | 0 |
| 2004 | 49 | 0 |
| 2005 | 50 | 0 |
| 2006 | 36 | 0 |
| 2007 | 19 | 0 |
| 2008 | 38 | 0 |
| 2009 | 30 | 0 |
| 2010 | 26 | 1 |
| 2011 | 25 | 0 |
| 2012 | 14 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2020 | 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.
1 device in this family has a Class I recall. 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K171651 | Excelsius GPSSummary page 7…Predicate Device Manufacturer 510(k)# Clearance Date ExcelsiusGPS instruments Globus Medical Inc. K171651 16 August 2017 Additional Predicate: Predicate Device Manufacturer… | 2017 |
| * | K220862 | E-GPS Navigated InstrumentsSummary page 7…Predicate Device Manufacturer 510(k)# Clearance Date E-GPS Navigated instruments Precision Spine, Inc. K220862 14 July 2022… | 2022 |
| † | K203247 | iFuse-TORQ™ Implant System | 2021 |
| † | K220195 | iFuse Bedrock Granite™ Implant System | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 82 of the 643 ancestors have a recall of any class; 1 has a Class I recall.
- 27 other devices also cite its predicate K171651.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for: Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacrolliitis. Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute…
Read the full statement (804 words)
The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for:
Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacrolliitis.
Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iIFuse TORQ Implant System procedures, 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 the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
The TORQ iGPS instruments and iGPS Drill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse TORQ Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
Use of the IGPS instruments is limited to use only with 10.0 mm and 11.5 mm fully threaded iFuse TORQ implants.
The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion in skeletally mature patients for the following conditions:
Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
To augment immobilization and stabilization of the sacroiliac joint in patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
When connected to compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
Spondylolisthesis
Trauma (i.e., fracture or dislocation)
Spinal stenosis
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Spinal tumor
Pseudarthrosis
Failed previous fusion
When connected to compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to thoracolumbar fusion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.
The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite Implant System procedures, 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 the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy.
The Granite iGPS instruments and iGPS Dirill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Bedrock Granite Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
Use of the IGPS instruments is limited to use only with the 9.5 mm and 10.5 mm iFuse Bedrock Granite implants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251780 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251780: iGPS Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251780
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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