NextAR TKA platform

GUDID 07630542771736

NextAR Modular Femoral Spacer - S4-7 Right

Medacta International SA

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 07630542771736
• NIH Device Record Key: ca1a0bae-bb84-4b1c-86f7-d591617fcaf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextAR TKA platform
• Version Model Number: 02.23.10.0082
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630542771736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202152

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

[07630542771736]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-08
• Device Publish Date: 2025-07-31

On-Brand Devices [NextAR TKA platform]

• 07630971281370: NextAR micrometric cutting guide cut slot
• 07630971281363: NextAR micrometric cutting guide connection plate
• 07630971281356: NextAR micrometric cutting guide
• 07630971281349: NextAR cut checker femur-tibia
• 07630971281332: NextAR 4in1 holder for GMK Efficiency
• 07630971281325: NextAR trial tibial baseplate holder for GMK Efficiency
• 07630971281318: NextAR curved stylus
• 07630971281301: NextAR straight stylus
• 07630971281295: NextAR modular tracker holder
• 07630971281288: NextAR tracker holder right
• 07630971281271: NextAR tracker holder left
• 07630971267565: NextAR active infrared tracker small (18)
• 07630971267558: NextAR infrared camera
• 07630345732170: Screwdriver Torx T15
• 07630345732163: NextAR drilling guide for sensor holders
• 07630345732156: NextAR sleeve for micrometric cutting guide
• 07630345732149: NextAR Cut checker conical connection
• 07630345732132: NextAR Slot checker conical connection
• 07630345732125: NextAR GMK Eff trial baseplate holder conical conn
• 07630345732118: NextAR GMK Eff 4in1 holder conical conn
• 07630345732101: NextAR large handle conical connection right
• 07630345732095: NextAR large handle conical connection left
• 07630345732088: NextAR small handle conical connection right
• 07630345732071: NextAR small handle conical connection left
• 07630345732064: NextAR curved stylus conical connection
• 07630345732057: NextAR Straight stylus conical connection
• 07630345732040: NextAR small target holder left
• 07630345732033: NextAR small camera holder left
• 07630345732026: NextAR small target holder right
• 07630345732019: NextAR small camera holder right
• 07630345732002: NextAR Micrometric guide small
• 07630345717962: NextAR 2.0 instruments tray
• 07630345749949: NextAR GMK Metal trial basepl holder conical conn
• 07630345749932: NextAR GMK 4in1 slot holder conical conn
• 07630345775702: NextAR Micrometric Guide Shim +4mm
• 07630345775696: NextAR Micrometric Guide Shim +3mm
• 07630345775689: NextAR Micrometric Guide Shim +2mm
• 07630345775672: NextAR Micrometric Guide Shim +1mm
• 07630345775665: NextAR Micrometric Guide Shim 0mm
• 07630345775658: NextAR Micrometric Guide Shim -1mm
• 07630345775641: NextAR Micrometric Guide Shim -2mm
• 07630345775634: NextAR Micrometric Guide Shim -3mm
• 07630345775627: NextAR Micrometric Guide Shim -4mm
• 07630345775610: NextAR Micrometric Guide – Height Adjustment
• 07630971289215: NextAR micrometric cutting guide connection fork
• 07630971289208: NextAR cutting guide GMK efficiency
• 07630971289192: NextAR cut verifier
• 07630971288829: NextAR PSI-free drilling guide tibia
• 07630971288812: NextAR PSI-free drilling guide femur
• 07630971288805: NextAR PSI-free tracker holder right