FDA.report

OptumSI Implant System

Primary DI
00850057247183
Brand
OptumSI Implant System
Company
SI Solutions, LLC
Model
11-11535
Device description
Sacroiliac Joint Fusion Implant, 11.5mm x 35mm
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OURSacroiliac Joint Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions

SubmissionSupplement
K251365000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251365000OptumSI Implant SystemSi Solutions, LLC2025-11-20OUR

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850057247183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057247183008500572471838500572471830850057247183

GMDN Terms

TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoatedAn implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

Device Sizes

TypeValueUnit
Length35Millimeter
Width11.5Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
120155935
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850057247008OptumSI Implant System11-115302025-12-16
00850057247015OptumSI Implant System12-000012025-12-16
00850057247022OptumSI Implant System12-000022025-12-16
00850057247039OptumSI Implant System12-000032025-12-16
00850057247046OptumSI Implant System12-000042025-12-16
00850057247053OptumSI Implant System12-000052025-12-16
00850057247060OptumSI Implant System12-000102025-12-16
00850057247077OptumSI Implant System12-000112025-12-16
00850057247084OptumSI Implant System12-000172025-12-16
00850057247091OptumSI Implant System12-000212025-12-16
00850057247107OptumSI Implant System12-000262025-12-16
00850057247114OptumSI Implant System12-000272025-12-16
00850057247121OptumSI Implant System12-000302025-12-16
00850057247138OptumSI Implant System12-000352025-12-16
00850057247145OptumSI Implant System12-000372025-12-16
00850057247152OptumSI Implant System12-000402025-12-16
00850057247169OptumSI Implant System12-000412025-12-16
00850057247176OptumSI Implant System12-000422025-12-16
00850057247190OptumSI Implant System11-115402025-12-16
00850057247206OptumSI Implant System11-115452025-12-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841193127996T-FIX™3Dsi Joint Fusion SystemCutting Edge Spine, LLCOUR2026-03-24
00810131882082TiLink InSite Disposable KitSURGENTEC, LLCOUR2026-03-09
00810131882730Joint Fusion Office KitSURGENTEC, LLCOUR2026-03-09
00810131882204TiLink-P Instrument Removal Tool - MetalSURGENTEC, LLCOUR2026-02-25
00810055525768iFuse INTRA Ti ImplantSi-Bone Inc.OUR2026-02-17
00889929072189NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-02-10
M719GSIX122L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX122S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1230SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1240SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1250SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200M0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200XL0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX201L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX201S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX2110SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX3000SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX3010SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1131050SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1131150SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1150SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1160SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX117L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX117S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1180SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1190550SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1190650SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1190750SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27