FDA.reportPublic FDA data

NextAR Hip Platform

Primary DI
07630542785702
Brand
NextAR Hip Platform
Company
Medacta International SA
Model
01.50.10.0028
Device description
NextAR Hip Impactor double offset
Published
2026-01-14
Public version status
New
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
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
07630542785702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542785702076305427857027630542785702

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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630542779244Surgical Manual Instrument03.52.10.08042026-03-24
07630542715303Orthopedic Manual Surgical Instrument01.10.10.34592025-10-08
07630542715310Orthopedic Manual Surgical Instrument01.10.10.34602025-10-08
07630542715327Orthopedic Manual Surgical Instrument01.10.10.34612025-10-08
07630542715334Orthopedic Manual Surgical Instrument01.10.10.34622025-10-22
07630542789984Surgical Manual Instrument02.12.10.31252026-03-19
07630542789991Surgical Manual Instrument02.12.10.31262026-03-19
07630542797576Surgical Manual Instrument02.12.10.31422026-03-19
07630699705486Surgical Manual Instrument02.12.10.31622026-03-19
07630699705493Surgical Manual Instrument02.12.10.31632026-03-19
07630699705509Surgical Manual Instrument02.12.10.31642026-03-19
07630699705516Surgical Manual Instrument02.12.10.31652026-03-19
07630699705523Surgical Manual Instrument02.12.10.31662026-03-19
07630542725562Surgical Manual Instrument01.10.10.11602026-03-17
07630542791482Spine Instruments03.75.10.06612026-03-13
07630971230880Surgical Manual Instrument03.51.10.02342026-03-02
07630542790799Mfinity Femoral System01.24.10.3002026-02-27
07630542790805Mfinity Femoral System01.24.10.3012026-02-27
07630542790812Mfinity Femoral System01.24.10.3022026-02-27
07630542790829Mfinity Femoral System01.24.10.3032026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290113781139C-arm adaptor enclosureAUGMEDICS LTDSBF2026-03-11
07630542722332NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542779626NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782183NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782190NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782206NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782213NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782220NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782237NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782466NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782473NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782480NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782497NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542782503NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785283NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785399NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785405NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785658NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785665NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785672NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785689NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785696NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785719NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785955NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785962NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785979NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542785986NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542728396NextAR™ SpineMedacta International SASBF2025-11-27
17290113781730X2 HeadsetAUGMEDICS LTDSBF2025-11-19
07290113781702X2 Accessories KitAUGMEDICS LTDSBF2025-11-19