FDA.reportPublic FDA data

OptumSI Implant System

Primary DI
00850057247220
Brand
OptumSI Implant System
Company
SI Solutions, LLC
Model
11-11555
Device description
Sacroiliac Joint Fusion Implant, 11.5mm x 55mm
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

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
00850057247220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057247220008500572472208500572472200850057247220

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length55Millimeter
Width11.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
120155935
Device count
1
Lot or batch
true
Expiration date on label
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
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
00850057247183OptumSI Implant System11-115352025-12-16
00850057247190OptumSI Implant System11-115402025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327075830ASNISStryker GmbHOUR2015-11-11
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07613327076301ASNISStryker GmbHOUR2015-11-11
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07613327077049ASNISStryker GmbHOUR2015-11-11
07613327077308ASNISStryker GmbHOUR2015-11-11
07613327077315ASNISStryker GmbHOUR2015-11-11
07613327077346ASNISStryker GmbHOUR2015-11-11
07613327077391ASNISStryker GmbHOUR2015-11-11
07613327077414ASNISStryker GmbHOUR2015-11-11
07613327077483ASNISStryker GmbHOUR2015-11-11
07613327077513ASNISStryker GmbHOUR2015-11-11
07613327077544ASNISStryker GmbHOUR2015-11-11
07613327077582ASNISStryker GmbHOUR2015-11-11
07613327077605ASNISStryker GmbHOUR2015-11-11
07613327077612ASNISStryker GmbHOUR2015-11-11
07613327077643ASNISStryker GmbHOUR2015-11-11
07613327077674ASNISStryker GmbHOUR2015-11-11
07613327077704ASNISStryker GmbHOUR2015-11-11
07613327077735ASNISStryker GmbHOUR2015-11-11
07613154158980NAStryker GmbHOUR2015-09-24
07613252232674ASNISStryker GmbHOUR2015-09-24
07613252232681ASNISStryker GmbHOUR2015-09-24
07613252232698ASNISStryker GmbHOUR2015-09-24
07613252232704ASNISStryker GmbHOUR2015-09-24
07613252232711ASNISStryker GmbHOUR2015-09-24
07613252232728ASNISStryker GmbHOUR2015-09-24
07613252232735ASNISStryker GmbHOUR2015-09-24