Ifuse Granite Implant System
iFuse Bedrock Granite combines a porous titanium-alloy fusion sleeve with a threaded section and solid post. The post provides placement and connection features similar to those of a…
iFuse Bedrock Granite combines a porous titanium-alloy fusion sleeve with a threaded section and solid post. The post provides placement and connection features similar to those of a pedicle fixation screw.
The implant supports sacroiliac fusion in a sacral-alar-iliac trajectory with compatible sacroiliac fusion-promoting devices. Connected to a SeaSpine Mariner construct, it also provides foundational sacropelvic stabilization.
Listed Item
13.5 mm x 105 mm iFuse Bedrock Granite Implant
Rod Connection and Instruments
The implant connects to Mariner through 5.5 or 6.0 mm titanium-alloy or cobalt-chromium rods. Open and minimally invasive instrument sets support placement. The implant itself is Ti-6Al-4V ELI titanium alloy and is offered in different lengths and diameters.
Who Else Makes It
Concentrated in Guangdong (1), Shandong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | SI-Bone, Inc., United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K220195 |
| Record published | 2022-05-31 |
| Record revised | 2022-11-28 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 45 to 120 mm; outer diameter 10.5 to 13.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 105070BG | Length 70 mm | In distribution |
| 135080BG | Length 80 mm | In distribution |
| 105080BG | Length 80 mm | In distribution |
| 105085BG | Length 85 mm | In distribution |
| 105055BG | Length 55 mm | In distribution |
| 115055BG | Length 55 mm | In distribution |
| 135095BG | Length 95 mm | In distribution |
| 105045BG | Length 45 mm | In distribution |
| 105050BG | Length 50 mm | In distribution |
| 135105BG | Length 105 mm | In distribution |
| 115100BG | Length 100 mm | In distribution |
| 125045BG | Length 45 mm | In distribution |
| 125100BG | Length 100 mm | In distribution |
| 125070BG | Length 70 mm | In distribution |
| 135060BG | Length 60 mm | In distribution |
| 115060BG | Length 60 mm | In distribution |
| 125110BG | Length 110 mm | In distribution |
| 135045BG | Length 45 mm | In distribution |
| 125075BG | Length 75 mm | In distribution |
| 105065BG | Length 65 mm | In distribution |
| 115045BG | Length 45 mm | In distribution |
| 115070BG | Length 70 mm | In distribution |
| 135070BG | Length 70 mm | In distribution |
| 115080BG | Length 80 mm | In distribution |
| 135090BG | Length 90 mm | In distribution |
| 125095BG | Length 95 mm | In distribution |
| 135115BG | Length 115 mm | In distribution |
| 125105BG | Length 105 mm | In distribution |
| 125050BG | Length 50 mm | In distribution |
| 105095BG | Length 95 mm | In distribution |
| 125055BG | Length 55 mm | In distribution |
| 105115BG | Length 115 mm | In distribution |
| 115120BG | Length 120 mm | In distribution |
| 135075BG | Length 75 mm | In distribution |
| 105105BG | Length 105 mm | In distribution |
| 115090BG | Length 90 mm | In distribution |
| 125080BG | Length 80 mm | In distribution |
| 135055BG | Length 55 mm | In distribution |
| 135085BG | Length 85 mm | In distribution |
| 115105BG | Length 105 mm | In distribution |
| 125085BG | Length 85 mm | In distribution |
| 135100BG | Length 100 mm | In distribution |
| 115065BG | Length 65 mm | In distribution |
| 115110BG | Length 110 mm | In distribution |
| 115050BG | Length 50 mm | In distribution |
| 115085BG | Length 85 mm | In distribution |
| 135065BG | Length 65 mm | In distribution |
| 125115BG | Length 115 mm | In distribution |
| 105075BG | Length 75 mm | In distribution |
| 125065BG | Length 65 mm | In distribution |
| 125090BG | Length 90 mm | In distribution |
| 105100BG | Length 100 mm | In distribution |
| 125060BG | Length 60 mm | In distribution |
| 135110BG | Length 110 mm | In distribution |
| 125120BG | Length 120 mm | In distribution |
| 115115BG | Length 115 mm | In distribution |
| 105110BG | Length 110 mm | In distribution |
| 135050BG | Length 50 mm | In distribution |
| 105090BG | Length 90 mm | In distribution |
| 105120BG | Length 120 mm | In distribution |
| 135120BG | Length 120 mm | In distribution |
| 115075BG | Length 75 mm | In distribution |
| 105060BG | Length 60 mm | In distribution |
| 115095BG | Length 95 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SI-LOK | Globus Medical, Inc. | 666 |
| Sacroiliac Joint Fusion System | Genesys Orthopedics Systems, LLC | 356 |
| SIros-X | Genesys Orthopedics Systems, LLC | 353 |
| PathLoc- SI Joint Fusion System | L&K Biomed Co., Ltd. | 229 |
| ARx SAI | Life Spine | 224 |
| Unity | Diomedical Co., Ltd. | 198 |
| SImmetry SI Joint Fusion System | Tenon Medical, Inc. | 173 |
| M.u.s.t. Sacral Iliac Screw and Pelvic Trauma System | Medacta International SA | 170 |
| Integrity-SI Fusion System | Lincotek Medical, LLC | 160 |
| Zespin SI Joint Fusion System | Aegis Spine | 150 |
| M.u.s.t. Sacral Iliac Screw System | Medacta International SA | 142 |
| Simmetry | Sivantage | 123 |
Showing 12 of 534. All products under Sacroiliac Joint Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253488 | 2026-02-11 |
| K253094 | 2025-10-09 |
| K241504 | 2024-08-19 |
| K241574 | 2024-07-02 |
| K233508 | 2024-01-26 |
| K231689 | 2023-06-30 |
| K222774 | 2022-12-22 |
| K222605 | 2022-09-29 |
| K213667 | 2022-06-10 |
| K220195 | 2022-05-26 |
| K203247 | 2021-02-25 |
| K193524 | 2020-03-31 |
| K190230 | 2019-04-03 |
| K182983 | 2018-11-27 |
| K162733 | 2017-03-10 |
| K160652 | 2016-06-03 |
| K152681 | 2016-03-01 |
| K151718 | 2015-10-29 |
| K150875 | 2015-07-22 |
| K150714 | 2015-04-17 |
| K141049 | 2014-07-23 |
| K131405 | 2013-10-16 |
| K123850 | 2013-04-01 |
| K122074 | 2012-10-12 |
| K110838 | 2011-04-21 |
| K092375 | 2009-09-04 |
| K080398 | 2008-11-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.