Sacroiliac Joint Fixation

FDA product code OUR · 121 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3040
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2005-08-26 – 2026-08-24

sacroiliac joint fusion

OUR 2026-08-24

TiLink-L™ SI Joint Fusion System

Applicant SurGenTec, LLC

K number K261381

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OUR 2026-04-08

CATAMARAN™ SI Joint Fusion System

Applicant Tenon Medical

K number K260477

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OUR 2026-02-11

iFuse INTRA Ti™ Implant System

Applicant SI-BONE, Inc.

K number K253488

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OUR 2026-01-29

Falco Fusion System

Applicant Mcnicoll Surgical, Inc.

K number K253611

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OUR 2026-01-28

Sacroiliac Joint Truss System (SJTS)

Applicant 4Web Medical

K number K252834

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OUR 2025-11-20

OptumSI Implant System

Applicant Si Solutions, LLC

K number K251365

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OUR 2025-10-22

SIros-X System

Applicant Genesys Spine

K number K252322

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OUR 2025-10-09

iFuse Bedrock Granite Implant System

Applicant SI-BONE, Inc.

K number K253094

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OUR 2025-10-07

Eminent Spine Posterior SI System

Applicant Eminent Spine

K number K250894

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OUR 2025-07-29

SImmetry+ System

Applicant Sivantage

K number K250647

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OUR 2025-07-09

panaSIa SI Fusion System

Applicant Wenzel Spine, Inc.

K number K250247

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OUR 2025-06-26

The Rialto™ SI Fusion System

Applicant Medtronic Sofamor Danek USA, Inc.

K number K251395

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OUR 2025-06-06

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

Applicant Si-Technology, LLC

K number K251525

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OUR 2025-06-06

Omnia Medical PsiF DNA™ System

Applicant Omnia Medical, LLC

K number K242431

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OUR 2025-06-03

Patriot SI Implant System

Applicant Spinal Simplicity, LLC

K number K250001

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OUR 2025-04-25

DYNAMIS™ Implant System

Applicant Promethean Restorative, LLC

K number K251075

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OUR 2025-03-21

Catamaran SI Joint Fusion System

Applicant Tenon Medical

K number K250403

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OUR 2025-03-14

NEXXT MATRIXX® SI System

Applicant Nexxt Spine

K number K243838

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OUR 2025-02-28

DYNAMIS™ SI Screw System

Applicant Promethean Restorative, LLC

K number K243565

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OUR 2024-12-27

TiLink-P SI Joint Fusion System

Applicant SurGenTec, LLC

K number K243835

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OUR 2024-11-21

TiLink-P Joint Fusion System

Applicant SurGenTec, LLC

K number K242414

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OUR 2024-08-21

TiLink-P SI Joint Fusion System

Applicant SurGenTec, LLC

K number K242141

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OUR 2024-08-19

iFuse TORQ TNT™ Implant System

Applicant SI-BONE, Inc.

K number K241504

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OUR 2024-08-13

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

Applicant Si-Technology, LLC

K number K241813

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OUR 2024-07-29

ARx® SAI Implant System

Applicant Life Spine, Inc.

K number K241464

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OUR 2024-07-02

iFuse TORQ® Implant System

Applicant SI-BONE, Inc.

K number K241574

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OUR 2024-06-04

Eminent Spine SI Screw System

Applicant Eminent Spine, LLC

K number K240505

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OUR 2024-04-20

BowTie™ SI Joint Fusion System

Applicant Sail Fusion, LLC

K number K232149

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OUR 2024-04-19

Patriot-SI Posterior Implant System

Applicant Spinal Simplicity, LLC

K number K232259

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OUR 2024-04-11

TiLink-P SI Joint Fusion System

Applicant SurGenTec, LLC

K number K240720

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OUR 2024-02-27

Camber Sacroiliac (SI) Fixation System

Applicant Camber Spine Technologies

K number K233972

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OUR 2024-02-23

PathLoc SI Joint Fusion System

Applicant L&K BIOMED Co., Ltd.

K number K240201

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OUR 2024-01-26

iFuse Bedrock Granite® Implant System

Applicant SI-BONE, Inc.

K number K233508

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OUR 2024-01-19

TORPEDO Implant System®

Applicant Deltacor GmbH

K number K230817

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OUR 2023-12-05

Liberty SI Lateral Implant System

Applicant Spinal Simplicity, LLC

K number K231923

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OUR 2023-10-27

SOLACE Sacroiliac Fixation System

Applicant Ht Medical, LLC Dba Xenix Medical

K number K233241

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OUR 2023-10-24

REUNION Sacroiliac Joint Fusion System

Applicant Astura Medical

K number K232211

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OUR 2023-10-17

TransLoc 3D

Applicant Foundation Fusion Solutions, LLC (Dba Cornerloc)

K number K232878

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OUR 2023-09-28

Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System

Applicant Lesspine Innovations

K number K232605

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OUR 2023-09-25

TiLink-P SI Joint Fusion System

Applicant SurGenTec, LLC

K number K230857

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OUR 2023-09-21

Integrity-SI® Fusion System

Applicant OsteoCentric Technologies

K number K230226

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OUR 2023-08-24

CATAMARAN SI Joint Fusion System

Applicant Tenon Medical, Inc.

K number K231944

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OUR 2023-08-15

Xenix Medical Sacroiliac Fixation System

Applicant Ht Medical D.B.A. Xenix Medical

K number K231829

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OUR 2023-08-03

TiLink-L Joint Fusion System

Applicant Surgentec

K number K231831

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OUR 2023-07-28

SI-Cure Sacroiliac Joint Fusion System

Applicant Alevio, LLC

K number K231951

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OUR 2023-07-14

PathLoc SI Joint Fusion System

Applicant L&K BIOMED Co., Ltd.

K number K231841

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OUR 2023-06-30

iFuse TORQ® Implant System

Applicant SI-BONE, Inc.

K number K231689

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OUR 2023-06-07

TiLink-L SI Joint Fusion System

Applicant SurGenTec, LLC

K number K230446

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OUR 2023-04-24

Kisar Stratford SI Screw System

Applicant Anjali Investments L.L.C

K number K220274

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OUR 2023-04-05

T-FIX™ 3DSI Joint Fusion System

Applicant Cutting Edge Spine, LLC

K number K230689

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OUR 2023-03-29

SiJoin®T3

Applicant Vgi Medical, Inc.

K number K213815

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OUR 2023-03-21

Entasis 3D Dual-Lead Sacroiliac Implant System

Applicant Corelink, LLC

K number K223708

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OUR 2023-01-20

ZESPIN SI Joint Fusion System

Applicant Aegis Spine, Inc.

K number K223521

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OUR 2023-01-18

SI-Cure Sacroiliac Joint Fusion System

Applicant Alevio, LLC

K number K223819

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OUR 2022-12-22

iFuse Bedrock Granite® Implant System

Applicant SI-BONE, Inc.

K number K222774

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OUR 2022-10-17

CASSATT™ SIJ Fixation System

Applicant Ctl Medical Corporation

K number K211785

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OUR 2022-10-13

UNITY Sacroiliac Joint Fixation System

Applicant Dio Medical Corporation

K number K222448

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OUR 2022-10-03

SILO TFX MIS Sacroiliac Joint Fixation System

Applicant Aurora Spine, Inc.

K number K221047

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OUR 2022-09-29

iFuse TORQ® Implant System

Applicant SI-BONE, Inc.

K number K222605

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OUR 2022-09-12

Integrity-SI Fusion System

Applicant OsteoCentric Technologies

K number K222512

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OUR 2022-09-02

Camber Sacroiliac (SI) Fixation System

Applicant Camber Spine Technologies, LLC

K number K203503

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OUR 2022-07-27

TransLoc 3D

Applicant Foundation Fusion Solutions, LLC (Dba Cornerloc)

K number K211496

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OUR 2022-06-30

ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System

Applicant Aegis Spine, Inc.

K number K221050

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OUR 2022-06-24

T-FIX® 3DSI Joint Fusion System

Applicant Cutting Edge Spine, LLC

K number K214123

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OUR 2022-06-10

iFuse-TORQ® Implant System

Applicant SI-BONE, Inc.

K number K213667

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OUR 2022-05-26

iFuse Bedrock Granite™ Implant System

Applicant SI-BONE, Inc.

K number K220195

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OUR 2022-04-11

TRELLIS™ SI Joint Fusion System

Applicant Orthofundamentals, LLC

K number K212962

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OUR 2022-03-01

Blue Topaz Sacroiliac Screw System

Applicant Osseus Fusion Systems, LLC

K number K213590

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OUR 2021-12-15

SIMPACT Sacroiliac Joint Fixation System

Applicant Life Spine, Inc.

K number K212903

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OUR 2021-09-09

Curiteva Sacroiliac Joint Fusion System

Applicant Curiteva, Inc.

K number K210402

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OUR 2021-08-31

Triton™ Sacroiliac Joint Fixation System

Applicant Choice Spine, LLC

K number K211449

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OUR 2021-03-25

FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K number K210667

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OUR 2021-03-23

Harvester SI: Sacroiliac Fixation System

Applicant Spinus International, Inc.

K number K203780

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OUR 2021-02-25

iFuse-TORQ™ Implant System

Applicant SI-BONE, Inc.

K number K203247

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OUR 2021-02-16

ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System

Applicant Aegis Spine

K number K210035

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OUR 2021-01-22

Advanced Research Medical Trident SI Screw System

Applicant Advanced Research Medical, LLC

K number K203373

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OUR 2021-01-13

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

Applicant Medacta International S.A.

K number K203671

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OUR 2020-11-18

FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K number K203138

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OUR 2020-09-18

Life Spine SIMPACT Sacroiliac Joint Fixation System

Applicant Life Spine, Inc.

K number K201538

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OUR 2020-09-15

FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K number K201664

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OUR 2020-08-05

NADIA SI Fusion System

Applicant Ilion Medical, Inc.

K number K190580

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OUR 2020-04-17

SI-Restore Sacroiliac Joint Fixation System

Applicant Biofusion Medical

K number K200868

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OUR 2020-04-02

FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K number K200696

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OUR 2020-03-31

SI-BONE iFuse Implant System®

Applicant SI-BONE, Inc.

K number K193524

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OUR 2019-12-03

M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System

Applicant Medacta International S.A.

K number K193083

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OUR 2019-09-26

Genesys Spine Sacroiliac Joint Fusion System

Applicant Genesys Spine

K number K191748

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OUR 2019-08-12

EVOL® -SI Joint Fusion System

Applicant Cutting Edge Spine, LLC

K number K190025

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OUR 2019-04-30

SambaScrew 3D SI Fusion System

Applicant Orthofix, Inc.

K number K183342

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OUR 2019-04-03

iFuse Implant System®

Applicant SI-BONE, Inc.

K number K190230

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OUR 2019-02-06

SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments

Applicant Globus Medical, Inc.

K number K183119

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OUR 2019-01-25

SI-Restore® Sacroiliac Joint Fixation System

Applicant Biofusion Medical

K number K182919

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OUR 2018-11-27

iFuse Implant System®

Applicant SI-BONE, Inc.

K number K182983

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OUR 2018-10-03

Outlet Sacroiliac Joint Fusion System

Applicant Sij Surgical

K number K181881

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OUR 2018-07-16

PathLoc-SI Joint Fusion System

Applicant L&K BIOMED Co., Ltd.

K number K181600

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OUR 2018-06-15

Life Spine SIMPACT Sacroiliac Joint Fixation System

Applicant Life Spine, Inc.

K number K180749

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OUR 2018-06-13

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

Applicant Tenon Medical, Inc.

K number K180818

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OUR 2018-04-26

UNITY Sacroiliac Joint Fixation System

Applicant Huvexel Co. , Ltd.

K number K173201

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OUR 2018-03-16

SI Screw System

Applicant Zavation Medical Products, LLC

K number K173752

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OUR 2017-08-02

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

Applicant Medacta International S.A.

K number K171595

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OUR 2017-05-05

SICAGE™ System

Applicant Sicage, LLC

K number K170475

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