FDA.reportPublic FDA data

OptumSI Implant System

Primary DI
00850057247114
Brand
OptumSI Implant System
Company
SI Solutions, LLC
Model
12-00027
Device description
Impactor
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251365000OptumSI Implant SystemSi Solutions, LLC2025-11-20OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850057247114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057247114008500572471148500572471140850057247114

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
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
00850057247183OptumSI Implant System11-115352025-12-16
00850057247190OptumSI Implant System11-115402025-12-16
00850057247206OptumSI Implant System11-115452025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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