FDA.reportPublic FDA data

MOTO Partial Knee System

Primary DI
07630345711823
Brand
MOTO Partial Knee System
Company
Medacta International SA
Model
02.18.EIF4.14.LLRL
Device description
E-CROSS tibial insert fix S4 - LATERAL - 14mm
Published
2021-11-19
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
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213071000MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.2021-11-16HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630345711823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345711823076303457118237630345711823

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee insertA sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).

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
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
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
05404028000922SurgiCase PlannerMaterialise NVHSX2025-05-14
00822409130153N/AOrtho Development CorporationHSX2025-03-17
00822409130160N/AOrtho Development CorporationHSX2025-03-17
00822409130177N/AOrtho Development CorporationHSX2025-03-17
00822409130184N/AOrtho Development CorporationHSX2025-03-17
00822409130191N/AOrtho Development CorporationHSX2025-03-17
00822409130207N/AOrtho Development CorporationHSX2025-03-17
00822409130214N/AOrtho Development CorporationHSX2025-03-17
00822409130221N/AOrtho Development CorporationHSX2025-03-17
00822409130238N/AOrtho Development CorporationHSX2025-03-17
00822409130245N/AOrtho Development CorporationHSX2025-03-17
00822409130252N/AOrtho Development CorporationHSX2025-03-17
00822409130269N/AOrtho Development CorporationHSX2025-03-17
00810129550221OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550238OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550245OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550016OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550054OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550092OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550146OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550160OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550177OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550191OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550207OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550214OvertureTiOverture Resurfacing IncHSX2023-10-18
00885556779989VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
00885556780039VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
E314SURGICASEKNEEPLAN0SurgiCase PlannerMaterialise NVHSX2018-10-17
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19