Femoral Component 31125PF

GUDID EPIS31125PF0

Episurf Operations AB

Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis Patellofemoral joint prosthesis

• Primary Device ID: EPIS31125PF0
• NIH Device Record Key: 9f4a2d09-996f-4a7d-8afd-9d93daeca640
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral Component
• Version Model Number: D25
• Catalog Number: 31125PF
• Company DUNS: 352393402
• Company Name: Episurf Operations AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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
HIBCC	EPIS31125PF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221048

FDA Product Code

• KRR: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [Femoral Component]

• EPIS51125PF0: 2xD25
• EPIS51120PF0: 2xD20
• EPIS51117PF0: 2xD17
• EPIS31129PF0: D29
• EPIS31125PF0: D25
• EPIS31120PF0: D20