FDA.reportPublic FDA data

Anatomic Shoulder Prosthesis

Primary DI
07630040712675
Brand
Anatomic Shoulder Prosthesis
Company
Medacta International SA
Model
04.01.0029
Device description
Humeral Anatomical Metaphysis – Cementless, Size 12, 135°
Published
2017-08-24
Public version status
Update
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
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170910000Medacta Anatomic Shoulder ProsthesisMedacta International S.A.2017-08-16KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630040712675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630040712675076300407126757630040712675

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
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

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Primary DI, Brand, Company table
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05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
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00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
10885862657244EquinoxeExactech, Inc.KWS2026-07-07
10885862657251EquinoxeExactech, Inc.KWS2026-07-07
10885862657268EquinoxeExactech, Inc.KWS2026-07-07
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10885862657312EquinoxeExactech, Inc.KWS2026-07-07
10885862657329EquinoxeExactech, Inc.KWS2026-07-07
10885862657336EquinoxeExactech, Inc.KWS2026-07-07
10885862657343EquinoxeExactech, Inc.KWS2026-07-07
10885862657350EquinoxeExactech, Inc.KWS2026-07-07
10885862657367EquinoxeExactech, Inc.KWS2026-07-07
10885862657374EquinoxeExactech, Inc.KWS2026-07-07
10885862657381EquinoxeExactech, Inc.KWS2026-07-07
10885862657398EquinoxeExactech, Inc.KWS2026-07-07
10885862657442EquinoxeExactech, Inc.KWS2026-07-07
10885862657459EquinoxeExactech, Inc.KWS2026-07-07