FDA.reportPublic FDA data

M.U.S.T. Sacral Iliac Screw System

Primary DI
07630030879609
Brand
M.U.S.T. Sacral Iliac Screw System
Company
Medacta International SA
Model
03.65.008
Device description
MUST-PT Ti Screw 7.3x110mm, Thread 35mm, Sterile
Published
2026-01-20
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

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
K171595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171595000M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.2017-08-02OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030879609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030879609076300308796097630030879609

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, coatedAn 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 metal [e.g., titanium (Ti)] with a porous plasma spray coating, and typically in the form of a cylinder or rod, possibly with a triangular cross-section. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630345700551NextAR TSA Platform5.3KSWNXAR2026-07-10
07630542776755Surgical Manual Instrument01.10.10.20922026-07-07
07630542778285Surgical Manual Instrument01.10.10.20932026-07-07
07630542778292Surgical Manual Instrument01.10.10.20942026-07-07
07630542791659Surgical Manual Instrument03.51.10.07412026-07-07
07630542788314AMIStem-P13.000092026-06-08
07630542788321AMIStem-P13.000102026-06-08
07630542788338AMIStem-P13.000112026-06-08
07630542788345AMIStem-P13.000122026-06-08
07630542788352AMIStem-P13.000132026-06-08
07630542788369AMIStem-P13.000142026-06-08
07630542788376AMIStem-P13.000152026-06-08
07630971243637AMIStem-P Short Neck01.18.4592020-01-29
07630971243644AMIStem-P Short Neck01.18.4602020-01-29
07630971243651AMIStem-P Short Neck01.18.4612020-01-29
07630971243668AMIStem-P Short Neck01.18.4622020-01-29
07630971243675AMIStem-P Short Neck01.18.4632020-01-29
07630971243682AMIStem-P Short Neck01.18.4642020-01-29
07630971243699AMIStem-P Short Neck01.18.4652020-01-29
07630971243705AMIStem-P Short Neck01.18.4662020-01-29

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