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

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

• 05404028000199 - Materialise Mimics Enlight: 2025-03-17 Materialise Mimics Enlight
• 05404028000281 - SurgiCase OOS: 2025-03-17 SurgiCase Mobile
• 05420060380747 - TRUMATCH: 2025-03-10 Titanium 3D Printed Guide, Bone harvesting
• 05420060380754 - TRUMATCH: 2025-03-10 Mandible Reconstruction kit
• 05420060380761 - TRUMATCH: 2025-03-10 Midface Reconstruction kit
• 05420060366116 - Match Point System: 2024-12-17 Guide and Bone model for Reverse Shoulder Arthroplasty (AltiVate® Reverse)
• 05420060366123 - Match Point System: 2024-12-17 Guide and Bone model for Total Shoulder Arthroplasty (AltiVate® Full Wedge)
• 05404028000090 - Mimics: 2024-12-11 Mimics Automatic Algorithms Knee MRI