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
07630542720680Surgical Manual Instrument03.22.10.10572026-10-14
07630542720895Surgical Manual Instrument03.22.10.11122026-10-14
07630542721045Surgical Manual Instrument03.22.10.11142026-10-14
07630542721052Surgical Manual Instrument03.22.10.11172026-10-14
07630542721069Surgical Manual Instrument03.22.10.11182026-10-14
07630542721304Surgical Manual Instrument03.22.10.12422026-10-14
07630542721311Surgical Manual Instrument03.22.10.12432026-10-14
07630542721335Surgical Manual Instrument03.22.10.13422026-10-14
07630699705950Shoulder System04.01.10.12142026-10-01
07630699705967Shoulder System04.01.10.12152026-10-01
07630699705974Shoulder System04.01.10.12162026-10-01
07630699705998Shoulder System04.01.10.12182026-10-01
07630699706001Shoulder System04.01.10.12192026-10-01
07630699706018Shoulder System04.01.10.12202026-10-01
07630699706032Shoulder System04.01.10.12222026-10-01
07630699706049Shoulder System04.01.10.12232026-10-01
07630699706056Shoulder System04.01.10.12242026-10-01
07630345775320Shoulder System04.01.10.06972026-09-28
07630345775375Shoulder System04.01.10.07022026-09-28
07630542727528Shoulder System04.01.10.08812026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899177United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899184United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899191United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899207United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899214United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899221United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899238United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899245United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899252United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886910896United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913361Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913378Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913385Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913392Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886913408Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15