FDA.reportPublic FDA data

M-Vizion Femoral Revision System Extension

Primary DI
07630542734953
Brand
M-Vizion Femoral Revision System Extension
Company
Medacta International SA
Model
01.22.183
Device description
Distal Stem Ø14mm L 220mm curved
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
07630542734953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542734953076305427349537630542734953

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) 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 contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07630542727535Shoulder System04.01.10.08822026-09-28
07630542727542Shoulder System04.01.10.08832026-09-28
07630542727559Shoulder System04.01.10.08842026-09-28
07630542794964Surgical Manual Instrument04.01.10.10132026-09-28
07630542794971Surgical Manual Instrument04.01.10.10142026-09-28
07630542794988Surgical Manual Instrument04.01.10.10152026-09-28
07630542794995Surgical Manual Instrument04.01.10.10162026-09-28
07630542795008Shoulder System04.01.10.10172026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707160G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
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