FDA.reportPublic FDA data

Navigation System for Knee surgery

Primary DI
07630699701792
Brand
Navigation System for Knee surgery
Company
Medacta International SA
Model
33.22.1000US
Device description
iMNS Navigator x US
Published
2026-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100314000IMNS MEDACTA NAVIGATION SYSTEM,33.221000USMedacta International S.A.2010-03-31HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630699701792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630699701792076306997017927630699701792

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation/tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures; it may be intended to overlay pre-acquired radiological images or real-time data [e.g., ultrasound (US)] for surgical navigation, and be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers 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., ENT, neurosurgery, CMF surgery].

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
false
Expiration date on label
false
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
07630345700551NextAR TSA Platform5.3KSWNXAR2026-07-10
07630345729316NextAR TSA Platform5.3SSWNXAR2026-04-13
07630345728975Navigation System for Knee surgery33.22.10002026-01-26
07630345725912NextAR Spine Platform98.46.NEXTAR2026-01-20
07630542722332NextAR Hip Platform09.23.10.IMU2026-01-14
07630542779626NextAR Hip Platform5.3HSWNXAR2026-01-14
07630542759130NextAR™ Spine03.57.10.02622025-11-14
07630542759147NextAR™ Spine03.57.10.02632025-11-14
07630542720390NextAR Spine Platform03.57.10.02032025-09-19
07630542720406NextAR Spine Platform03.57.10.02042025-09-19
07630542720413NextAR Spine Platform03.57.10.02052025-09-19
07630542720420NextAR Spine Platform03.57.10.02062025-09-19
07630542720437NextAR Spine Platform03.57.10.02072025-09-19
07630542720444NextAR Spine Platform03.57.10.02082025-09-19
07630542720451NextAR Spine Platform03.57.10.02092025-09-19
07630542765346NextAR (TM) Shoulder Platform04.01.10.09022025-09-17
07630542765353NextAR (TM) Shoulder Platform04.01.10.09032025-09-17
07630542765360NextAR (TM) Shoulder Platform04.01.10.09042025-09-17
07630542765421NextAR (TM) Shoulder Platform04.01.10.09102025-09-17
07630542765438NextAR (TM) Shoulder Platform04.01.10.09112025-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503713Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503720Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503942Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503959Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless SteelMEDTRONIC NAVIGATION, INC.HAW2026-08-17
00199150067664Stealth AXiS™ GEHC CRANIAL INTEGRATION KITMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00763000989958Stealth AXiS™ GEHC Craniotomy Transducer TrackerMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification DeviceMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00199150054466N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00763000381141N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.HAW2026-08-07
G076A900687A0Localite TMS Navigator TSLOCALITE GmbHHAW2026-08-03
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25