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131 FDA 510(k) clearances · Product code

89 daysmedian time to decision
263 days90th percentile
131clearances measured

FDA profile

Official device name
Sacroiliac Joint Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Medical specialty
Orthopedic
Flags
Implant
FDA definition
sacroiliac joint fusion
Adverse events (MAUDE)
2017: 157 · 2018: 137 · 2019: 175 · 2020: 148 · 2021: 154 · 2022: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CATAMARAN™ SI Joint Fusion System (K260477)Tenon Medical2026-04-08
iFuse INTRA Ti™ Implant System (K253488)SI-BONE, Inc.2026-02-11
Falco Fusion System (K253611)Mcnicoll Surgical, Inc.2026-01-29
Sacroiliac Joint Truss System (SJTS) (K252834)4Web Medical2026-01-28
OptumSI Implant System (K251365)Si Solutions, LLC2025-11-20
SIros-X System (K252322)Genesys Spine2025-10-22
iFuse Bedrock Granite Implant System (K253094)SI-BONE, Inc.2025-10-09
Eminent Spine Posterior SI System (K250894)Eminent Spine2025-10-07
SImmetry+ System (K250647)Sivantage2025-07-29
panaSIa SI Fusion System (K250247)Wenzel Spine, Inc.2025-07-09
The Rialto™ SI Fusion System (K251395)Medtronic Sofamor Danek USA, Inc.2025-06-26
Omnia Medical PsiF DNA™ System (K242431)Omnia Medical, LLC2025-06-06
SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (K251525)Si-Technology, LLC2025-06-06
Patriot SI Implant System (K250001)Spinal Simplicity, LLC2025-06-03
DYNAMIS™ Implant System (K251075)Promethean Restorative, LLC2025-04-25
Catamaran SI Joint Fusion System (K250403)Tenon Medical2025-03-21
NEXXT MATRIXX® SI System (K243838)Nexxt Spine2025-03-14
DYNAMIS™ SI Screw System (K243565)Promethean Restorative, LLC2025-02-28
TiLink-P SI Joint Fusion System (K243835)SurGenTec, LLC2024-12-27
TiLink-P Joint Fusion System (K242414)SurGenTec, LLC2024-11-21
TiLink-P SI Joint Fusion System (K242141)SurGenTec, LLC2024-08-21
iFuse TORQ TNT™ Implant System (K241504)SI-BONE, Inc.2024-08-19
SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (K241813)Si-Technology, LLC2024-08-13
ARx® SAI Implant System (K241464)Life Spine, Inc.2024-07-29
iFuse TORQ® Implant System (K241574)SI-BONE, Inc.2024-07-02
Eminent Spine SI Screw System (K240505)Eminent Spine, LLC2024-06-04
BowTie™ SI Joint Fusion System (K232149)Sail Fusion, LLC2024-04-20
Patriot-SI Posterior Implant System (K232259)Spinal Simplicity, LLC2024-04-19
TiLink-P SI Joint Fusion System (K240720)SurGenTec, LLC2024-04-11
Camber Sacroiliac (SI) Fixation System (K233972)Camber Spine Technologies2024-02-27
PathLoc SI Joint Fusion System (K240201)L&K BIOMED Co., Ltd.2024-02-23
iFuse Bedrock Granite® Implant System (K233508)SI-BONE, Inc.2024-01-26
TORPEDO Implant System® (K230817)Deltacor GmbH2024-01-19
Liberty SI Lateral Implant System (K231923)Spinal Simplicity, LLC2023-12-05
SOLACE Sacroiliac Fixation System (K233241)Ht Medical, LLC Dba Xenix Medical2023-10-27
REUNION Sacroiliac Joint Fusion System (K232211)Astura Medical2023-10-24
TransLoc 3D (K232878)Foundation Fusion Solutions, LLC (Dba Cornerloc)2023-10-17
Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System (K232605)Lesspine Innovations2023-09-28
TiLink-P SI Joint Fusion System (K230857)SurGenTec, LLC2023-09-25
Integrity-SI® Fusion System (K230226)OsteoCentric Technologies2023-09-21
CATAMARAN SI Joint Fusion System (K231944)Tenon Medical, Inc.2023-08-24
Xenix Medical Sacroiliac Fixation System (K231829)Ht Medical D.B.A. Xenix Medical2023-08-15
TiLink-L Joint Fusion System (K231831)Surgentec2023-08-03
SI-Cure Sacroiliac Joint Fusion System (K231951)Alevio, LLC2023-07-28
PathLoc SI Joint Fusion System (K231841)L&K BIOMED Co., Ltd.2023-07-14
iFuse TORQ® Implant System (K231689)SI-BONE, Inc.2023-06-30
TiLink-L SI Joint Fusion System (K230446)SurGenTec, LLC2023-06-07
Kisar Stratford SI Screw System (K220274)Anjali Investments L.L.C2023-04-24
T-FIX™ 3DSI Joint Fusion System (K230689)Cutting Edge Spine, LLC2023-04-05
SiJoin®T3 (K213815)Vgi Medical, Inc.2023-03-29
Entasis 3D Dual-Lead Sacroiliac Implant System (K223708)Corelink, LLC2023-03-21
ZESPIN SI Joint Fusion System (K223521)Aegis Spine, Inc.2023-01-20
SI-Cure Sacroiliac Joint Fusion System (K223819)Alevio, LLC2023-01-18
iFuse Bedrock Granite® Implant System (K222774)SI-BONE, Inc.2022-12-22
CASSATT™ SIJ Fixation System (K211785)Ctl Medical Corporation2022-10-17
UNITY Sacroiliac Joint Fixation System (K222448)Dio Medical Corporation2022-10-13
SILO TFX MIS Sacroiliac Joint Fixation System (K221047)Aurora Spine, Inc.2022-10-03
iFuse TORQ® Implant System (K222605)SI-BONE, Inc.2022-09-29
Integrity-SI Fusion System (K222512)OsteoCentric Technologies2022-09-12
Camber Sacroiliac (SI) Fixation System (K203503)Camber Spine Technologies, LLC2022-09-02
TransLoc 3D (K211496)Foundation Fusion Solutions, LLC (Dba Cornerloc)2022-07-27
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System (K221050)Aegis Spine, Inc.2022-06-30
T-FIX® 3DSI Joint Fusion System (K214123)Cutting Edge Spine, LLC2022-06-24
iFuse-TORQ® Implant System (K213667)SI-BONE, Inc.2022-06-10
iFuse Bedrock Granite™ Implant System (K220195)SI-BONE, Inc.2022-05-26
TRELLIS™ SI Joint Fusion System (K212962)Orthofundamentals, LLC2022-04-11
Blue Topaz Sacroiliac Screw System (K213590)Osseus Fusion Systems, LLC2022-03-01
SIMPACT Sacroiliac Joint Fixation System (K212903)Life Spine, Inc.2021-12-15
Curiteva Sacroiliac Joint Fusion System (K210402)Curiteva, Inc.2021-09-09
Triton™ Sacroiliac Joint Fixation System (K211449)Choice Spine, LLC2021-08-31
FIREBIRD SI Fusion System (K210667)Orthofix, Inc.2021-03-25
Harvester SI: Sacroiliac Fixation System (K203780)Spinus International, Inc.2021-03-23
iFuse-TORQ™ Implant System (K203247)SI-BONE, Inc.2021-02-25
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (K210035)Aegis Spine2021-02-16
Advanced Research Medical Trident SI Screw System (K203373)Advanced Research Medical, LLC2021-01-22
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K203671)Medacta International S.A.2021-01-13
FIREBIRD SI Fusion System (K203138)Orthofix, Inc.2020-11-18
Life Spine SIMPACT Sacroiliac Joint Fixation System (K201538)Life Spine, Inc.2020-09-18
FIREBIRD SI Fusion System (K201664)Orthofix, Inc.2020-09-15
NADIA SI Fusion System (K190580)Ilion Medical, Inc.2020-08-05
SI-Restore Sacroiliac Joint Fixation System (K200868)Biofusion Medical2020-04-17
FIREBIRD SI Fusion System (K200696)Orthofix, Inc.2020-04-02
SI-BONE iFuse Implant System® (K193524)SI-BONE, Inc.2020-03-31
M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System (K193083)Medacta International S.A.2019-12-03
Genesys Spine Sacroiliac Joint Fusion System (K191748)Genesys Spine2019-09-26
EVOL® -SI Joint Fusion System (K190025)Cutting Edge Spine, LLC2019-08-12
SambaScrew 3D SI Fusion System (K183342)Orthofix, Inc.2019-04-30
iFuse Implant System® (K190230)SI-BONE, Inc.2019-04-03
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments (K183119)Globus Medical, Inc.2019-02-06
SI-Restore® Sacroiliac Joint Fixation System (K182919)Biofusion Medical2019-01-25
iFuse Implant System® (K182983)SI-BONE, Inc.2018-11-27
Outlet Sacroiliac Joint Fusion System (K181881)Sij Surgical2018-10-03
PathLoc-SI Joint Fusion System (K181600)L&K BIOMED Co., Ltd.2018-07-16
Life Spine SIMPACT Sacroiliac Joint Fixation System (K180749)Life Spine, Inc.2018-06-15
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (K180818)Tenon Medical, Inc.2018-06-13
UNITY Sacroiliac Joint Fixation System (K173201)Huvexel Co. , Ltd.2018-04-26
SI Screw System (K173752)Zavation Medical Products, LLC2018-03-16
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K171595)Medacta International S.A.2017-08-02
SICAGE™ System (K170475)Sicage, LLC2017-05-05
iFuse Implant System® - iFuse-3D implant (K162733)SI-BONE, Inc.2017-03-10
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