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 Life Spine, Inc..

131
Total
131
Cleared
121d
Avg days
2005
Since
131 devices
97–120 of 131
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 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 Feb 04, 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237
Corelink, LLC
Orthopedic · 178d
Cleared Feb 22, 2015
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
K141246
Life Spine, Inc.
Orthopedic · 284d
Cleared Mar 25, 2014
SILEX SACROILIAC JOINT FUSION SYSTEM
K140079
X-Spine Systems, Inc.
Orthopedic · 71d
Cleared Mar 11, 2013
SILEX SACROILIAC JOINT FUSION SYSTEM
K123702
X-Spine Systems, Inc.
Orthopedic · 98d
Cleared May 29, 2012
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472
Medtronic Sofamor Danek
Orthopedic · 466d
Cleared Aug 26, 2005
SIJF CANNULATED SCREW SYSTEM
K051296
Depuy Spine, Inc.
Orthopedic · 100d