OUR · Sacroiliac Joint Fixation

Orthopedic · 21 CFR 888.3040 · Class 2

Overview

Product CodeOUR
Device NameSacroiliac Joint Fixation
Regulation21 CFR 888.3040
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification Rationale

Class II.

Recent Cleared Devices (20 of 131)

Showing 20 most recent of 131 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalApr 8, 2026SESE
K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.Feb 11, 2026SESE
K253611Falco Fusion SystemMcnicoll Surgical, Inc.Jan 29, 2026SESE
K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalJan 28, 2026SESE
K251365OptumSI Implant SystemSi Solutions, LLCNov 20, 2025SESE
K252322SIros-X SystemGenesys SpineOct 22, 2025SESE
K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.Oct 9, 2025SESE
K250894Eminent Spine Posterior SI SystemEminent SpineOct 7, 2025SESE
K250647SImmetry+ SystemSivantageJul 29, 2025SESE
K250247panaSIa SI Fusion SystemWenzel Spine, Inc.Jul 9, 2025SESE
K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.Jun 26, 2025SESE
K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLCJun 6, 2025SESE
K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLCJun 6, 2025SESE
K250001Patriot SI Implant SystemSpinal Simplicity, LLCJun 3, 2025SESE
K251075DYNAMIS™ Implant SystemPromethean Restorative, LLCApr 25, 2025SESE
K250403Catamaran SI Joint Fusion SystemTenon MedicalMar 21, 2025SESE
K243838NEXXT MATRIXX® SI SystemNexxt SpineMar 14, 2025SESE
K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLCFeb 28, 2025SESE
K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLCDec 27, 2024SESE
K242414TiLink-P Joint Fusion SystemSurGenTec, LLCNov 21, 2024SESE

Top Applicants

Innolitics

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