FDA.reportPublic FDA data

Sacroiliac Joint Fusion System

Primary DI
M719GSISO095650
Brand
Sacroiliac Joint Fusion System
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GSI-SO09565
Device description
9.5mm x 65mm SIros-O Implant
Published
2023-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K191748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191748000Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine2019-09-26OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GSISO095650PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length65Millimeter
Outer Diameter9.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5123817070info@genesysspine.com

Regulatory Flags#

DUNS number
017921066
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M179GSI265STS0Sacroiliac Joint Fusion1GSI265-ST-S2026-07-14
M719G120140SIros-X12026-07-14
M719GGSI265XLGS0Sacroiliac Joint Fusion1GSI265-XLG-S2026-07-14
M719GL2290TiLock1GL2292026-07-14
M719GLL100QC03DP Lumbar Interbody System1GLL100-QC2026-07-14
M719GLL101QC03DP Lumbar Interbody System1GLL101-QC2026-07-14
M719GLL106QC03DP Lumbar Interbody System1GLL106-QC2026-07-14
M719GLL107QC03DP Lumbar Interbody System1GLL107-QC2026-07-14
M719GCL05L0Apache1GCL-05-L2015-08-31
M719GCL06L0Apache1GCL-06-L2015-08-31
M719GCL06S0Apache1GCL-06-S2015-08-31
M719GCL07L0Apache1GCL-07-L2015-08-31
M719GCL07S0Apache1GCL-07-S2015-08-31
M719GCL08L0Apache1GCL-08-L2015-08-31
M719GCL08S0Apache1GCL-08-S2015-08-31
M719GCL09L0Apache1GCL-09-L2015-08-31
M719GCL09S0Apache1GCL-09-S2015-08-31
M719GCL10L0Apache1GCL-10-L2015-08-31
M719GCL10S0Apache1GCL-10-S2015-08-31
M719GCL11L0Apache1GCL-11-L2015-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613327076301ASNISStryker GmbHOUR2015-11-11
07613327076554ASNISStryker GmbHOUR2015-11-11
07613327076721ASNISStryker GmbHOUR2015-11-11
07613327076929ASNISStryker GmbHOUR2015-11-11
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
07613154158980NAStryker GmbHOUR2015-09-24
07613252232674ASNISStryker GmbHOUR2015-09-24
07613252232681ASNISStryker GmbHOUR2015-09-24
07613252232698ASNISStryker GmbHOUR2015-09-24
07613252232704ASNISStryker GmbHOUR2015-09-24