FDA.reportPublic FDA data

NextAR Hip Platform

Primary DI
07630542782497
Brand
NextAR Hip Platform
Company
Medacta International SA
Model
01.50.10.0010
Device description
NextAR Hip 3 pin hinge left
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBFOrthopedic Augmented RealityNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252847000NextAR Hip PlatformMedacta International S.A.2026-01-09SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542782497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542782497076305427824977630542782497

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630971230156Spine Instruments03.30.10.20372026-05-12
07630971236745Spine Instruments03.30.10.20382026-05-12
07630971236752Spine Instruments03.30.10.20392026-05-12
07630971236769Spine Instruments03.30.10.20402026-05-12
07630971236776Spine Instruments03.30.10.20412026-05-12
07630971236783Spine Instruments03.30.10.20422026-05-12
07630971236790Spine Instruments03.30.10.20432026-05-12
07630971236806Spine Instruments03.30.10.20442026-05-12
07630971236813Spine Instruments03.30.10.20452026-05-12
07630971236820Spine Instruments03.30.10.20462026-05-12
07630542763748MectaLIF 3D Metal Anterior03.38.0012026-05-08
07630542763755MectaLIF 3D Metal Anterior03.38.0022026-05-08
07630542763762MectaLIF 3D Metal Anterior03.38.0032026-05-08
07630542763779MectaLIF 3D Metal Anterior03.38.0042026-05-08
07630542763786MectaLIF 3D Metal Anterior03.38.0052026-05-08
07630542763793MectaLIF 3D Metal Anterior03.38.0062026-05-08
07630542763809MectaLIF 3D Metal Anterior03.38.0072026-05-08
07630542763816MectaLIF 3D Metal Anterior03.38.0082026-05-08
07630542763823MectaLIF 3D Metal Anterior03.38.0092026-05-08
07630542763830MectaLIF 3D Metal Anterior03.38.0102026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760297030490KneePlusPIXEE MEDICALSBF2026-05-27
07630345729316NextAR TSA PlatformMedacta International SASBF2026-04-13
07630345725912NextAR Spine PlatformMedacta International SASBF2026-01-20
07630542720390NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720406NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720413NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720420NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720437NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720444NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720451NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542735448NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735455NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735462NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735479NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735486NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735493NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735509NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735516NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735523NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735530NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735547NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735554NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735561NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735578NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542714566NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542714573NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542714580NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542714597NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542714603NextAR Spine PlatformMedacta International SASBF2024-11-07
07630542723087NextAR TSA Platform Medacta International SASBF2024-03-08