Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SI-BONE, Inc. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
164 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253488 | iFuse INTRA Ti™ Implant System | SI-BONE, Inc. | 2026-02-11 | 110 | 0 |
| K253094 | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | 2025-10-09 | 16 | 0 |
| K251780 | iGPS Navigation Instruments | SI-BONE, Inc. | 2025-09-15 | 97 | 0 |
| K241504 | iFuse TORQ TNT™ Implant System | SI-BONE, Inc. | 2024-08-19 | 83 | 0 |
| K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2024-07-02 | 29 | 0 |
| K232800 | Navigation Tracking Instruments | SI-BONE, Inc. | 2024-02-23 | 164 | 0 |
| K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024-01-26 | 87 | 0 |
| K231689 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2023-06-30 | 21 | 0 |
| K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2022-12-22 | 99 | 0 |
| K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022-09-29 | 31 | 0 |
| K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022-06-10 | 200 | 0 |
| K220195 | iFuse Bedrock Granite™ Implant System | SI-BONE, Inc. | 2022-05-26 | 122 | 0 |
| K203247 | iFuse-TORQ™ Implant System | SI-BONE, Inc. | 2021-02-25 | 113 | 0 |
| K203110 | iFuse Implant System - iFuse Navigation | SI-BONE, Inc. | 2020-11-09 | 25 | 0 |
| K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | 2020-03-31 | 103 | 0 |
| K190230 | iFuse Implant System® | SI-BONE, Inc. | 2019-04-03 | 56 | 0 |
| K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018-11-27 | 29 | 0 |
| K172268 | iFuse Implant System- iFuse Navigation | SI-BONE, Inc. | 2017-10-31 | 96 | 0 |
| K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017-03-10 | 162 | 0 |
| K161893 | Neuromonitoring Kit | SI-BONE, Inc. | 2016-10-18 | 99 | 0 |
| K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016-06-03 | 87 | 0 |
| K152681 | iFuse Implant System(R) | SI-BONE, Inc. | 2016-03-01 | 165 | 0 |
| K151718 | iFuse Implant System | SI-BONE, Inc. | 2015-10-29 | 126 | 0 |
| K150875 | iFuse Implant System | SI-BONE, Inc. | 2015-07-22 | 112 | 0 |
| K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015-04-17 | 29 | 0 |
| K141049 | IFUSE IMPLANT SYSTEM | SI-BONE, Inc. | 2014-07-23 | 91 | 0 |
| K131405 | IFUSE IMPLANT SYSTEM | SI-BONE, Inc. | 2013-10-16 | 154 | 0 |
| K123850 | IFUSE IMPLANT SYSTEM | SI-BONE, Inc. | 2013-04-01 | 108 | 0 |
| K122074 | IFUSE IMPLANT SYSTEM | SI-BONE, Inc. | 2012-10-12 | 88 | 0 |
| K110838 | IFUSE IMPLANT SYSTEM | SI-BONE, Inc. | 2011-04-21 | 27 | 0 |
| K092375 | MODIFICATION TO SI JOINT FUSION SYSTEM | SI-BONE, Inc. | 2009-09-04 | 30 | 0 |
| K080398 | SI JOINT FUSION SYSTEM | SI-BONE, Inc. | 2008-11-26 | 287 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda