OUR · Class II · 21 CFR 888.3040

FDA Product Code OUR: Sacroiliac Joint Fixation

Under FDA product code OUR, sacroiliac joint fixation devices are cleared for the surgical stabilization and fusion of the sacroiliac joint.

The sacroiliac joint connects the spine to the pelvis and is a significant source of lower back and buttock pain. OUR devices — typically minimally invasive implant systems of screws or rods — immobilize the joint to promote bone fusion and relieve chronic pain unresponsive to conservative treatment.

OUR devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include SI-BONE, Inc., SurGenTec, LLC and Zyga Technology, Inc..

132
Total
132
Cleared
121d
Avg days
2005
Since
132 devices
97–120 of 132
Cleared Apr 26, 2018
UNITY Sacroiliac Joint Fixation System
K173201
Huvexel Co. , Ltd.
Orthopedic · 206d
Cleared Mar 16, 2018
SI Screw System
K173752
Zavation Medical Products, LLC
Orthopedic · 98d
Cleared Aug 02, 2017
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K171595
Medacta International S.A.
Orthopedic · 63d
Cleared May 05, 2017
SICAGE™ System
K170475
Sicage, LLC
Orthopedic · 78d
Cleared Mar 10, 2017
iFuse Implant System® - iFuse-3D implant
K162733
SI-BONE, Inc.
Orthopedic · 162d
Cleared Jan 18, 2017
Siconus SI Joint Fixation System
K162121
Camber Spine Technologies
Orthopedic · 170d
Cleared Dec 14, 2016
Integrity-SI TM Fusion System
K161755
Coorstek Medical
Orthopedic · 170d
Cleared Nov 14, 2016
PathLoc-SI Joint Fusion System
K153656
L & K Biomed Co., Ltd.
Orthopedic · 329d
Cleared Aug 12, 2016
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
K161210
Medtronic Sofamor Danek
Orthopedic · 106d
Cleared Jun 03, 2016
iFUSE Implant System
K160652
SI-BONE, Inc.
Orthopedic · 87d
Cleared Mar 01, 2016
iFuse Implant System(R)
K152681
SI-BONE, Inc.
Orthopedic · 165d
Cleared Feb 04, 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237
Corelink, LLC
Orthopedic · 178d
Cleared Oct 29, 2015
iFuse Implant System
K151718
SI-BONE, Inc.
Orthopedic · 126d
Cleared Aug 12, 2015
SI-TECHNOLOGY® SI-DESIS® SCREWS
K151462
Si-Technology, LLC
Orthopedic · 72d
Cleared Aug 05, 2015
SImmetry Sacroiliac Joint Fusion System
K151818
Zyga Technology, Inc.
Orthopedic · 30d
Cleared Jul 22, 2015
iFuse Implant System
K150875
SI-BONE, Inc.
Orthopedic · 112d
Cleared Apr 24, 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017
Spinefrontier, Inc.
Orthopedic · 109d
Cleared Apr 17, 2015
SI-BONE iFuse Implant System
K150714
SI-BONE, Inc.
Orthopedic · 29d
Cleared Feb 22, 2015
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
K141246
Life Spine, Inc.
Orthopedic · 284d
Cleared Jan 15, 2015
SImmetry Sacroiliac Joint Fusion System
K141549
Zyga Technology, Inc.
Orthopedic · 218d
Cleared Oct 10, 2014
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
K141106
Folsom Metal Products, Inc. Dba Frontier Devices
Orthopedic · 164d
Cleared Jul 23, 2014
IFUSE IMPLANT SYSTEM
K141049
SI-BONE, Inc.
Orthopedic · 91d
Cleared Mar 25, 2014
SILEX SACROILIAC JOINT FUSION SYSTEM
K140079
X-Spine Systems, Inc.
Orthopedic · 71d
Cleared Oct 16, 2013
IFUSE IMPLANT SYSTEM
K131405
SI-BONE, Inc.
Orthopedic · 154d