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
07630030883576Mpact 3D Metal Foam25070.2236HC2026-09-04
07630030883583Mpact 3D Metal Foam25070.2238HC2026-09-04
07630030883590Mpact 3D Metal Foam25070.2240HC2026-09-04
07630030883606Mpact 3D Metal Foam25070.2242HC2026-09-04
07630030883613Mpact 3D Metal Foam25070.2244HC2026-09-04
07630030883620Mpact 3D Metal Foam25070.2246HC2026-09-04
07630030883637Mpact 3D Metal Foam25070.2248HC2026-09-04
07630030883644Mpact 3D Metal Foam25070.2250HC2026-09-04
07630030883651Mpact 3D Metal Foam25070.2252HC2026-09-04
07630030883668Mpact 3D Metal Foam25070.2254HC2026-09-04
07630030883675Mpact 3D Metal Foam25070.2256HC2026-09-04
07630030883682Mpact 3D Metal Foam25070.2258HC2026-09-04
07630030883699Mpact 3D Metal Foam25070.2840HC2026-09-04
07630030883705Mpact 3D Metal Foam25070.2842HC2026-09-04
07630030883712Mpact 3D Metal Foam25070.2844HC2026-09-04
07630030883729Mpact 3D Metal Foam25070.2846HC2026-09-04
07630030883736Mpact 3D Metal Foam25070.2848HC2026-09-04
07630030883743Mpact 3D Metal Foam25070.2850HC2026-09-04
07630030883750Mpact 3D Metal Foam25070.2852HC2026-09-04
07630030883767Mpact 3D Metal Foam25070.2854HC2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707047Signature ONE Software PackageOrthosoft IncMBF2026-07-10
00889024701540Identity® Shoulder SystemZimmer, Inc.MBF2026-06-10
00889024702127Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702134Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702141Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702158Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702165Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702172Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702189Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702196Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702202Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024704916Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704923Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704930Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704947Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704954Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704961Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704978Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704985Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704992Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705005Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705012Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705029Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705036Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705043Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705050Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705067Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705074Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705081Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705098Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10