FDA.reportPublic FDA data

MOTO PFJ System

Primary DI
07630345705068
Brand
MOTO PFJ System
Company
Medacta International SA
Model
02.15.701R
Device description
TiNbN coated Patello Femoral Joint S1 R
Published
2021-11-18
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
07630345705068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345705068076303457050687630345705068

GMDN Terms#

Term, Definition table
TermDefinition
Patellofemoral joint prosthesisA sterile implantable device designed to replace the patellofemoral articulating surface of the knee to treat isolated patellofemoral disease, typically osteoarthritis. The device is made of metal (e.g., oxidized zirconium alloy) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it may include fixation devices (e.g., pegs) for implantation which is intended to be performed with bone cement.

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
07630699705240Surgical Manual Instrument03.22.10.11652026-10-21
07630699705257Surgical Manual Instrument03.22.10.11662026-10-21
07630699705264Surgical Manual Instrument03.22.10.12672026-10-21
07630699705271Surgical Manual Instrument03.22.10.12682026-10-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810129550009OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550023OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550030OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550047OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550061OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550078OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550085OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550108OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550115OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550122OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550139OvertureTiOverture Resurfacing IncHSX2026-10-18
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