FDA.reportPublic FDA data

AMIStem C Femoral Stems

Primary DI
07630971212541
Brand
AMIStem C Femoral Stems
Company
Medacta International SA
Model
01.18.149
Device description
AMIStem-C Std. Cemented Femoral stem size 00
Published
2020-01-23
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
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193433000AMIStem-CMedacta International S.A.2020-01-09LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630971212541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630971212541076309712125417630971212541

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with 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
00192629032064LineageMicroport Orthopedics Inc.LZO2026-08-18
00192629032033LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032040LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032057LineageMicroport Orthopedics Inc.LZO2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19