FDA.reportPublic FDA data

Shoulder System

Primary DI
07630345716781
Brand
Shoulder System
Company
Medacta International SA
Model
04.01.0284
Device description
Humeral eccentric reverse metaphysis +0mm/+3mm
Published
2021-03-29
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
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210207000Humeral Eccentric Reverse MetaphysisMedacta International S.A.2021-03-26PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630345716781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345716781076303457167817630345716781

GMDN Terms#

Term, Definition table
TermDefinition
Total shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

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
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
07630971243712AMIStem-P Short Neck01.18.4672020-01-29
07630971243729AMIStem-P Short Neck01.18.4682020-01-29
07630971243736AMIStem-P Short Neck01.18.4692020-01-29
07630971243743AMIStem-P Short Neck01.18.4702020-01-29
07630971243750AMIStem-P Short Neck01.18.4712020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2026-05-28
08033390002233SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390115667SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390115711SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121484SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121507SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121514SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121521SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121545SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121569SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121583SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121590SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121613SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121637SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121644SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121668SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121682SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121699SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121927SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121972SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121989SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122009SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122023SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122030SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122047SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390153119SMR ShoulderLIMACORPORATE SPAMBF2024-07-26