FDA.reportPublic FDA data

OptumSI Implant System

Primary DI
00850057247077
Brand
OptumSI Implant System
Company
SI Solutions, LLC
Model
12-00011
Device description
Pin Holder
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00850057247077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057247077008500572470778500572470770850057247077

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
Lot or batch
true
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
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
00850057247206OptumSI Implant System11-115452025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-07-17
18257200140084Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200140091Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143368Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143375Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143382Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143399Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143405Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143412Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143429Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143436Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143443Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143450Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146079Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146086Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146093Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146109Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146116Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146123Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146130Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146147Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146154Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146161Firebird SI FusionOrthofix US LLCOUR2026-07-17
M179GSI265STS0Sacroiliac Joint FusionGenesys Orthopedics Systems LLCOUR2026-07-14
M719G120140SIros-XGenesys Orthopedics Systems LLCOUR2026-07-14
M719GGSI265XLGS0Sacroiliac Joint FusionGenesys Orthopedics Systems LLCOUR2026-07-14
00889929072738NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-05-01
07613327075830ASNISStryker GmbHOUR2015-11-11
07613327076189ASNISStryker GmbHOUR2015-11-11