BKS Total PSI KNM-OD01-00-01

GUDID 05420060360015

MRI Guides and Bone Models for Total Knee Arthroplasty

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit

• Primary Device ID: 05420060360015
• NIH Device Record Key: df4717b9-1d18-42bd-8c41-4507354cc265
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BKS Total PSI
• Version Model Number: KNM-OD01-00-01
• Catalog Number: KNM-OD01-00-01
• Company DUNS: 373139427
• Company Name: Materialise NV
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420060360015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221337

FDA Product Code

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

Sterilization

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

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

[05420060360015]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-29
• Device Publish Date: 2022-09-21

Devices Manufactured by Materialise NV

• 05420060380792 - TRUMATCH: 2025-09-19 TRUMATCH TJR Mandible Polyamide Kit
• 05420060380808 - TRUMATCH: 2025-09-19 TRUMATCH TJR Mandible Polyamide Kit with duplicate bridge
• 05420060380815 - TRUMATCH: 2025-09-19 TRUMATCH TJR Midface Polyamide Kit
• 05420060380822 - TRUMATCH: 2025-09-19 TRUMATCH TJR Midface Polyamide Kit with duplicate bridge
• 05420060380839 - TRUMATCH: 2025-09-19 TRUMATCH TJR Mandible Titanium Kit
• 05420060380846 - TRUMATCH: 2025-09-19 TRUMATCH TJR Mandible Titanium Kit with duplicate bridge
• 05420060380853 - TRUMATCH: 2025-09-19 TRUMATCH TJR Midface Titanium Kit
• 05420060380860 - TRUMATCH: 2025-09-19 TRUMATCH TJR Midface Titanium Kit with duplicate bridge