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
07630542762482GMK Extension02.12.0110APFL2026-09-18
07630542762499GMK Extension02.12.0110APFR2026-09-18
07630542762505GMK Extension02.12.0111APFL2026-09-18
07630542762512GMK Extension02.12.0111APFR2026-09-18
07630542762529GMK Extension02.12.0112APFL2026-09-18
07630542762536GMK Extension02.12.0112APFR2026-09-18
07630542762543GMK Extension02.12.0113APFL2026-09-18
07630542762550GMK Extension02.12.0113APFR2026-09-18
07630542762567GMK Extension02.12.0114APFL2026-09-18
07630542762574GMK Extension02.12.0114APFR2026-09-18
07630542762581GMK Extension02.12.0117APFL2026-09-18
07630542762598GMK Extension02.12.0117APFR2026-09-18
07630542762604GMK Extension02.12.0120APFL2026-09-18
07630542762611GMK Extension02.12.0120APFR2026-09-18
07630542762628GMK Extension02.12.0210APFL2026-09-18
07630542762635GMK Extension02.12.0210APFR2026-09-18
07630542762642GMK Extension02.12.0211APFL2026-09-18
07630542762659GMK Extension02.12.0211APFR2026-09-18
07630542762666GMK Extension02.12.0212APFL2026-09-18
07630542762673GMK Extension02.12.0212APFR2026-09-18

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
00885556779989VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
00885556780039VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
E314SURGICASEKNEEPLAN0SurgiCase PlannerMaterialise NVHSX2018-10-17
07613327127423INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127485INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19