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 May 26, 2022 as substantially equivalent to K193524 (SI-BONE, Inc., 2020) and 2 other predicates after a 122-day review. Its family tree reaches back 16 generations to 1993. 32 later devices descend from it.
- Decided
- May 26, 2022
- Review
- 122 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K930834 (1993). 160 ancestors in all, the oldest K842956 (1984). 32 later devices descend from it, 6 citing it directly.
- Root · 16 generations backK930834 AcutractAcu Med, Inc. · 1993
- 12 generations between
- 3 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 2 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- 1 generation backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- This deviceK220195 iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022
- Descendant · cites it directly · 20 of its ownK222774 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 2 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · 2 generations on · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
- Descendant · 3 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
- Descendant · cites it directly · 4 of its ownK241574 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024
Show all 16 generations
- Root · 16 generations backK930834 AcutractAcu Med, Inc. · 1993
- 15 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 14 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 13 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 12 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 11 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 10 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 9 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 8 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 7 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 6 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 5 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 4 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 3 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 2 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- 1 generation backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- This deviceK220195 iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022 · cites it directly20descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 2 generations on11descendants
- K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · 2 generations on5descendants
- K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 3 generations on4descendants
- K241574iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −15 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −14 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −13 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −12 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −11 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −10 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −9 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −8 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −7 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −6 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −5 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −4 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −3 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −2 | K190230 | iFuse Implant System® | SI-BONE, Inc. | 2019 | — |
| −1 | K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | 2020 | — |
| 0 (this device) | K220195 | iFuse Bedrock Granite™ Implant System | SI-BONE, Inc. | 2022 | — |
| +1 | K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2022 | — |
| +2 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +2 | K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 | — |
| +3 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
| +1 | K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 10 | 0 |
| 2026 | 10 | 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 30.8 · 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 |
|---|---|---|---|
| * | K193524 | SI-BONE iFuse Implant System®Summary page 5…iFuse-3D Implant System SI-BONE, Inc. March 31, 2020 K193524 Additional Predicate Manufacturer 510(k)#… | 2020 |
| * | K212692 | Mariner Pedicle Screw SystemSummary page 5…Mariner Pedicle Screw September 21, Orthopedics K212692 System® 2021… | 2021 |
| * | K172268 | iFuse Implant System- iFuse NavigationSummary page 5…iFuse Implant System- October 31, SI-BONE, Inc. K172268 iFuse Navigation 2017 IV. DEVICE DESCR… | 2017 |
What descends from it? (32)
See all 326 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222774 | iFuse Bedrock Granite® Implant System | 2022 | 20 |
| K241574 | iFuse TORQ® Implant System | 2024 | 4 |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | 2023 | 3 |
| K262067 | iFuse Granite Onyx™ Implant System | 2026 | 0 |
| K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor… | 2026 | 0 |
| K252834 | Sacroiliac Joint Truss System (SJTS) | 2026 | 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 160 ancestors have a recall of any class.
- Of its descendants, K222774 (SI-BONE, Inc., 2022) has gone furthest, with 20 descendants of its own.
- 8 other devices also cite its predicate K193524.
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 6months. •To augment immobilization and stabilization of the sacroiliac joint in skeletally…
Read the full statement (281 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 6months.
•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 the SeaSpine Mariner Pedicle Screw System, 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 withdegeneration 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
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/K220195 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220195: iFuse Bedrock Granite™ Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220195
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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