FDA.reportPublic FDA data

M-Vizion Femoral Revision System Extension

Primary DI
07630345706621
Brand
M-Vizion Femoral Revision System Extension
Company
Medacta International SA
Model
01.22.10.0785
Device description
Curved broach L220 ø 16
Published
2026-09-21
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
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260173000M-Vizion Femoral Revision System ExtensionMedacta International S.A.2026-09-17LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630345706621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345706621076303457066217630345706621

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
07630040738767Surgical Manual Instrument01.22.10.00512026-09-21
07630345706584M-Vizion Femoral Revision System Extension01.22.10.07812026-09-21
07630345706591M-Vizion Femoral Revision System Extension01.22.10.07822026-09-21
07630345706607M-Vizion Femoral Revision System Extension01.22.10.07832026-09-21
07630345706614M-Vizion Femoral Revision System Extension01.22.10.07842026-09-21
07630345706638M-Vizion Femoral Revision System Extension01.22.10.07862026-09-21
07630345706645M-Vizion Femoral Revision System Extension01.22.10.07872026-09-21
07630345706652M-Vizion Femoral Revision System Extension01.22.10.07882026-09-21
07630345706669M-Vizion Femoral Revision System Extension01.22.10.07892026-09-21
07630345706676M-Vizion Femoral Revision System Extension01.22.10.07902026-09-21
07630345706683M-Vizion Femoral Revision System Extension01.22.10.07912026-09-21
07630345706690M-Vizion Femoral Revision System Extension01.22.10.07922026-09-21
07630345706706M-Vizion Femoral Revision System Extension01.22.10.07932026-09-21
07630345706713M-Vizion Femoral Revision System Extension01.22.10.07942026-09-21
07630345706720M-Vizion Femoral Revision System Extension01.22.10.07952026-09-21
07630542702112Surgical Manual Instrument01.22.10.01742026-09-21
07630542723162M-Vizion Femoral Revision System Extension01.22.10.04022026-09-21
07630542728563M-Vizion Femoral Revision System Extension01.22.10.07792026-09-21
07630542728570M-Vizion Femoral Revision System Extension01.22.10.07802026-09-21
07630542734670M-Vizion Femoral Revision System Extension01.22.0992026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896732United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896749United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896756United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896763United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896770United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896787United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24