FDA.reportPublic FDA data

Trellis SI Joint Fusion System

Primary DI
G204OFSI1135FT0
Brand
Trellis SI Joint Fusion System
Company
Orthofundamentals, LLC
Model
OFSI1135FT
Device description
11mm x 35mm 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
G204OFSI1135FT0PrimaryHIBCC0

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
Length35Millimeter
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
07613327075830ASNISStryker GmbHOUR2015-11-11
07613327076189ASNISStryker 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