FDA.reportPublic FDA data

NextAR TKA Platform

Primary DI
07630542770845
Brand
NextAR TKA Platform
Company
Medacta International SA
Model
16.1327
Device description
MyKnee NAR MIS Eff FemCutBl_Ass-CT-GMK-RM-7
Published
2025-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
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
07630542770845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542770845076305427708457630542770845

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.

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
07630030883576Mpact 3D Metal Foam25070.2236HC2026-09-04
07630030883583Mpact 3D Metal Foam25070.2238HC2026-09-04
07630030883590Mpact 3D Metal Foam25070.2240HC2026-09-04
07630030883606Mpact 3D Metal Foam25070.2242HC2026-09-04
07630030883613Mpact 3D Metal Foam25070.2244HC2026-09-04
07630030883620Mpact 3D Metal Foam25070.2246HC2026-09-04
07630030883637Mpact 3D Metal Foam25070.2248HC2026-09-04
07630030883644Mpact 3D Metal Foam25070.2250HC2026-09-04
07630030883651Mpact 3D Metal Foam25070.2252HC2026-09-04
07630030883668Mpact 3D Metal Foam25070.2254HC2026-09-04
07630030883675Mpact 3D Metal Foam25070.2256HC2026-09-04
07630030883682Mpact 3D Metal Foam25070.2258HC2026-09-04
07630030883699Mpact 3D Metal Foam25070.2840HC2026-09-04
07630030883705Mpact 3D Metal Foam25070.2842HC2026-09-04
07630030883712Mpact 3D Metal Foam25070.2844HC2026-09-04
07630030883729Mpact 3D Metal Foam25070.2846HC2026-09-04
07630030883736Mpact 3D Metal Foam25070.2848HC2026-09-04
07630030883743Mpact 3D Metal Foam25070.2850HC2026-09-04
07630030883750Mpact 3D Metal Foam25070.2852HC2026-09-04
07630030883767Mpact 3D Metal Foam25070.2854HC2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345729316NextAR TSA PlatformMedacta International SASBF2026-04-13
07630345725912NextAR Spine PlatformMedacta International SASBF2026-01-20
07630542722332NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542759130NextAR™ SpineMedacta International SASBF2025-11-14
07630542759147NextAR™ SpineMedacta International SASBF2025-11-14
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
07630542765346NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765353NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765360NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765421NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765438NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
04056481146672Mixed Reality Spine NavigationBrainlab SESBF2025-07-31
00810180350013ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDSBF2025-07-29
04056481143985Mixed Reality Spine NavigationBrainlab SESBF2025-05-31
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