510(k) · Cleared
ClearediFuse Bedrock Granite® Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SI-BONE, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Dec 22, 2022 as substantially equivalent to K220195 (SI-BONE, Inc., 2022) after a 99-day review. Its family tree reaches back 17 generations to 1993. 20 later devices descend from it.
- Decided
- Dec 22, 2022
- Review
- 99 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K930834 (1993). 161 ancestors in all, the oldest K842956 (1984). 20 later devices descend from it, 6 citing it directly.
- Root · 17 generations backK930834 AcutractAcu Med, Inc. · 1993
- 13 generations between
- 3 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- 2 generations backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- 1 generation backK220195 iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022
- This deviceK222774 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022
- Descendant · cites it directly · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · cites it directly · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
- Descendant · 2 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK240951 Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024
Show all 17 generations
- Root · 17 generations backK930834 AcutractAcu Med, Inc. · 1993
- 16 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 15 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 14 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 13 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 12 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 11 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 10 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 9 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 8 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 7 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 6 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 5 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 4 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 3 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- 2 generations backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- 1 generation backK220195 iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022
- This deviceK222774 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · cites it directly11descendants
- K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · cites it directly5descendants
- K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 2 generations on4descendants
- K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024 · 2 generations on2descendants
- K240951Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −16 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −15 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −14 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −13 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −12 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −11 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −10 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −9 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −8 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −7 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −6 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −5 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −4 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −3 | K190230 | iFuse Implant System® | SI-BONE, Inc. | 2019 | — |
| −2 | K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | 2020 | — |
| −1 | K220195 | iFuse Bedrock Granite™ Implant System | SI-BONE, Inc. | 2022 | — |
| 0 (this device) | K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2022 | — |
| +1 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +1 | K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 | — |
| +2 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
| +2 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | — |
| +2 | K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 11 | 0 |
| 1996 | 3 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 9 | 0 |
| 2004 | 6 | 0 |
| 2005 | 12 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K220195 | iFuse Bedrock Granite™ Implant SystemSummary page 5…anufacturer 510(k)# Clearance Date iFuse Bedrock Granite® Implant SI-BONE, Inc. K220195 May 26, 2022 System IV. DEVICE DESCRIPTION The iFuse Bedrock Granite® Implant System consists… | 2022 |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232275 | Invictus® Spinal Fixation System | 2023 | 11 |
| K233508 | iFuse Bedrock Granite® Implant System | 2024 | 5 |
| K262067 | iFuse Granite Onyx™ Implant System | 2026 | 0 |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | 2025 | 0 |
| K253094 | iFuse Bedrock Granite Implant System | 2025 | 0 |
| K231744 | VyLink™ Spinal Screw System | 2023 | 0 |
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 29 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 23 of the 161 ancestors have a recall of any class.
- Of its descendants, K232275 (Alphatec Spine, Inc., 2023) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K220195.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 iFuse Bedrock Granite@ Implant System is intended for sacroiliac joint fusion 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 skeletally…
Read the full statement (323 words)
The iFuse Bedrock Granite@ Implant System is intended for sacroiliac joint fusion 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 skeletally mature 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 ofdiscogenic 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
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 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. iFuse Bedrock Granite Navigation instruments are intended to be used with the Medtronic StealthStation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222774: iFuse Bedrock Granite® Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222774
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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