FDA.reportPublic FDA data

Trellis SI Joint Fusion System

Primary DI
G204OFSI1145FT0
Brand
Trellis SI Joint Fusion System
Company
Orthofundamentals, LLC
Model
OFSI1145FT
Device description
11mm x 45mm Fully Threaded Trellis SI Joint Fusion Screw
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K212962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212962000TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC2022-04-11OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G204OFSI1145FT0PrimaryHIBCC0

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
Length45Millimeter
Outer Diameter11Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
617-398-0317info@orthofundamentals.com

Regulatory Flags#

DUNS number
118041137
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G204OFSI24TP0Trellis SI Joint Fusion SystemOFSI24TP2024-12-11
G204OFSISPLY0Trellis SI Joint Fusion SystemOFSISPLY2024-12-11
G204OFSIANDG0Trellis SI Joint Fusion SystemOFSIANDG2025-05-07
G204OFSI16OF0Trellis SI Joint Fusion SystemOFSI16OF2024-12-11
G204OFSI20OF0Trellis SI Joint Fusion SystemOFSI20OF2024-12-11
G204OFSIALLO0AlloGr8 Posterior Allograft SystemOFSIALLO2024-12-11
G204OFSIINST0Trellis SI Joint Fusion SystemOFSIINST2024-12-11
G204OFSIPLIN0Trellis SI Joint Fusion SystemOFSIPLIN2024-12-11
G204OFSIREM0Trellis SI Joint Fusion SystemOFSIREM2024-12-11
G204OFSI09300Trellis SI Joint Fusion SystemOFSI09302024-07-15
G204OFSI09350Trellis SI Joint Fusion SystemOFSI09352024-07-15
G204OFSI09400Trellis SI Joint Fusion SystemOFSI09402024-07-15
G204OFSI09450Trellis SI Joint Fusion SystemOFSI09452024-07-15
G204OFSI09500Trellis SI Joint Fusion SystemOFSI09502024-07-15
G204OFSI09550Trellis SI Joint Fusion SystemOFSI09552024-07-15
G204OFSI09600Trellis SI Joint Fusion SystemOFSI09602024-07-15
G204OFSI09650Trellis SI Joint Fusion SystemOFSI09652024-07-15
G204OFSI09700Trellis SI Joint Fusion SystemOFSI09702024-07-15
G204OFSI11300Trellis SI Joint Fusion SystemOFSI11302024-07-15
G204OFSI1130FT0Trellis SI Joint Fusion SystemOFSI1130FT2024-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613327076301ASNISStryker GmbHOUR2015-11-11