MOBIO™ Total Knee System 8821321711

GUDID 00843575108494

CR Tibial Insert, Standard UHMWPE, Size HJ/7-10, 11 mm

B-ONE ORTHO, CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 00843575108494
• NIH Device Record Key: 943891f6-9875-4654-b316-33f0420a0da4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOBIO™ Total Knee System
• Version Model Number: 8821321711
• Catalog Number: 8821321711
• Company DUNS: 081315444
• Company Name: B-ONE ORTHO, CORP.
• 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	00843575108494 [Primary]

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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: 2021-06-10
• Device Publish Date: 2021-06-02

On-Brand Devices [MOBIO™ Total Knee System]

• 00843575106438: EM Tibial Alignment Guide, Non-Spiked Uprod, Standard
• 00843575106421: EM Tibial Alignment Guide, Spiked Uprod, Standard
• 00843575106414: PS+ Tibial Insert, Size HJ/7-10+, 25mm thickness, Vitamin E UHMWPE
• 00843575106407: PS+ Tibial Insert, Size HJ/7-10+, 22mm thickness, Vitamin E UHMWPE
• 00843575106391: PS+ Tibial Insert, Size FG/4-9+, 25mm thickness, Vitamin E UHMWPE
• 00843575106384: PS+ Tibial Insert, Size FG/4-9+, 22mm thickness, Vitamin E UHMWPE
• 00843575106377: PS+ Tibial Insert, Size DE/3-7+, 25mm thickness, Vitamin E UHMWPE
• 00843575106360: PS+ Tibial Insert, Size DE/3-7+, 22mm thickness, Vitamin E UHMWPE
• 00843575106353: PS+ Tibial Insert, Size BC/3-6+, 25mm thickness, Vitamin E UHMWPE
• 00843575106346: PS+ Tibial Insert, Size BC/3-6+, 22mm thickness, Vitamin E UHMWPE
• 00843575106339: PS+ Tibial Insert, Size A/3-4+, 25mm thickness, Vitamin E UHMWPE
• 00843575106322: PS+ Tibial Insert, Size A/3-4+, 22mm thickness, Vitamin E UHMWPE
• 00843575106315: PS+ Tibial Insert, Size A/1-2+, 25mm thickness, Vitamin E UHMWPE
• 00843575106308: PS+ Tibial Insert, Size A/1-2+, 22mm thickness, Vitamin E UHMWPE
• 00843575106292: PS Tibial Insert, Size HJ/7-10, 25mm thickness, Vitamin E UHMWPE
• 00843575106285: PS Tibial Insert, Size HJ/7-10, 22mm thickness, Vitamin E UHMWPE
• 00843575106278: PS Tibial Insert, Size FG/4-9, 25mm thickness, Vitamin E UHMWPE
• 00843575106261: PS Tibial Insert, Size FG/4-9, 22mm thickness, Vitamin E UHMWPE
• 00843575106254: PS Tibial Insert, Size DE/3-7, 25mm thickness, Vitamin E UHMWPE
• 00843575106247: PS Tibial Insert, Size DE/3-7, 22mm thickness, Vitamin E UHMWPE
• 00843575106230: PS Tibial Insert, Size BC/3-6, 25mm thickness, Vitamin E UHMWPE
• 00843575106223: PS Tibial Insert, Size BC/3-6, 22mm thickness, Vitamin E UHMWPE
• 00843575106216: PS Tibial Insert, Size A/1-4, 25mm thickness, Vitamin E UHMWPE
• 00843575106209: PS Tibial Insert, Size A/1-4, 22mm thickness , Vitamin E UHMWPE
• 00843575106193: Thick PS/PS PLUS Insert Trials Tray
• 00843575106186: PS Femoral 9-10; ARS Tray
• 00843575106179: PS Femoral Prep 3-8; ARS Tray
• 00843575106162: PS Femoral 1-2; ARS Tray
• 00843575106155: PS PLUS Insert Trials Tray
• 00843575106148: PS Insert Trials Tray
• 00843575106131: Tibial Preparation Tray
• 00843575106124: Tibial Resection Tray
• 00843575106117: PS Femoral Trials 3-8 Tray
• 00843575106100: PS Femoral 9-10; AR Tray
• 00843575106094: PS Femoral Prep 3-8; AR Tray
• 00843575106087: PS Femoral 1-2; AR Tray
• 00843575106070: PS Femoral 9-10; PR Tray
• 00843575106063: PS Femoral Prep 3-8; PR Tray
• 00843575106056: PS Femoral 1-2; PR Tray
• 00843575106049: Femoral Resection Tray
• 00843575106032: Patella Resection Tray
• 00843575105974: Pin Caddy
• 00843575105967: General Tray
• 00843575105950: Sterilization Tray Lid
• 00843575105929: Femoral Impactor
• 00843575105912: Tibial Baseplate Impactor
• 00843575105905: Tibial Insert Impactor
• 00843575104779: AR Sizer and Rotation Guide
• 00843575104762: PR Sizer and Rotation Guide
• 00843575104755: Patella Resection Stylus