FDA.reportPublic FDA data

Mfinity Femoral System

Primary DI
07630542796623
Brand
Mfinity Femoral System
Company
Medacta International SA
Model
01.24.10.158
Device description
M-Finity L broach size 8 - extraction teeth
Published
2026-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251166000Mfinity Femoral SystemMedacta International S.A.2025-06-13MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542796623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542796623076305427966237630542796623

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
488227125
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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.MEH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899177United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899184United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899191United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899207United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899214United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899221United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899238United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899245United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899252United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886910896United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913361Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913378Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913385Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913392Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913408Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15