FDA.reportPublic FDA data

NextAR TKA Platform

Primary DI
07630345749949
Brand
NextAR TKA Platform
Company
Medacta International SA
Model
02.23.10.0045
Device description
NextAR GMK Metal trial basepl holder conical conn
Published
2022-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
SBFOrthopedic Augmented RealityNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193559000NextAR TKA PlatformMedacta Inernational SA2020-07-10SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630345749949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345749949076303457499497630345749949

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking systemA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/localizers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630542788314AMIStem-P13.000092026-06-08
07630542788321AMIStem-P13.000102026-06-08
07630542788338AMIStem-P13.000112026-06-08
07630542788345AMIStem-P13.000122026-06-08
07630542788352AMIStem-P13.000132026-06-08
07630542788369AMIStem-P13.000142026-06-08
07630542788376AMIStem-P13.000152026-06-08
07630971243637AMIStem-P Short Neck01.18.4592020-01-29
07630971243644AMIStem-P Short Neck01.18.4602020-01-29
07630971243651AMIStem-P Short Neck01.18.4612020-01-29
07630971243668AMIStem-P Short Neck01.18.4622020-01-29
07630971243675AMIStem-P Short Neck01.18.4632020-01-29
07630971243682AMIStem-P Short Neck01.18.4642020-01-29
07630971243699AMIStem-P Short Neck01.18.4652020-01-29
07630971243705AMIStem-P Short Neck01.18.4662020-01-29
07630971243712AMIStem-P Short Neck01.18.4672020-01-29
07630971243729AMIStem-P Short Neck01.18.4682020-01-29
07630971243736AMIStem-P Short Neck01.18.4692020-01-29
07630971243743AMIStem-P Short Neck01.18.4702020-01-29
07630971243750AMIStem-P Short Neck01.18.4712020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084604003OptiVu Shoulder Adapter HandleMR Surgical Solutions LLCSBF2026-06-03
00850084604010OptiVu Shoulder Pin InserterMR Surgical Solutions LLCSBF2026-06-03
00850084604027OptiVu Shoulder Cut GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604034OptiVu Shoulder StylusMR Surgical Solutions LLCSBF2026-06-03
00850084604041OptiVu Shoulder Reaming GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604058OptiVu Shoulder Clocking GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604065OptiVu Shoulder Humeral Reference RodMR Surgical Solutions LLCSBF2026-06-03
00850084604072OptiVu Shoulder Scapular Reference RodMR Surgical Solutions LLCSBF2026-06-03
00850084604089OptiVu Shoulder Sterile TrayMR Surgical Solutions LLCSBF2026-06-03
00850084604096OptiVu Shoulder Software ApplicationMR Surgical Solutions LLCSBF2026-06-03
00850084604102OptiVu Shoulder Humeral GaugeMR Surgical Solutions LLCSBF2026-06-03
00850084604119OptiVu Shoulder Tracker KitMR Surgical Solutions LLCSBF2026-06-03
00850084604126OptiVu Shoulder Scapula Anchor PinMR Surgical Solutions LLCSBF2026-06-03
00843575106445MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106452MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106469MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106476MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106483MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106490MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106506MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106513MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106520MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106537MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106544MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106551MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106568MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106575MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106582MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106599MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107619MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29