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The MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions:

• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• Revision of previous unsuccessful knee replacement or other procedure
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques

Additional Indications for the PS and PS+:

• Ligamentous instability requiring implant bearing surface geometries with increased constraint
• Absent or nonfunctioning posterior cruciate ligament
• Severe anteroposterior instability of the knee joint

The MOBIO Total Knee System is intended for implantation with bone cement only.

MOBIO Total Knee System components are not intended for use with other knee systems.

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial tray, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The purpose of this submission is to introduce a line extension to the b-ONE™ MOBIO™ Total Knee System CR/CR PLUS Tibial Insert components and PS/PS PLUS Tibial Insert Components. Compatibility with the b-ONE™ MOBIO™ Total Knee System tibial baseplate and femoral components remains the same. There is no allowed interchangeability with systems manufactured by other companies.

The subject b-ONE™ MOBIO™ Tibial Inserts are made from UHMWPE GUR® 1020-E Crosslinked with .1% tocopherol and conventional UHMWPE GUR® 1020. This material is the same as that used in the reference and predicate devices. The pre-assembled locking wire is the same locking wire used in the existing Tibial Inserts and is manufactured from Cobalt Chrome conforming to ASTM F90.

All system components are supplied sterile and are single use devices.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "MOBIO Total Knee System." It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to previously cleared devices.

However, the document does not contain any information regarding the acceptance criteria or a study that proves the device meets specific performance criteria in terms of an AI/algorithm's performance. This device is a total knee replacement system, which is a physical implant, not an AI or algorithm-based diagnostic or assistive technology. Therefore, the questions posed in the prompt regarding acceptance criteria for AI performance, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, or training sets are not applicable to the content of this document.

The "Performance Data" section lists non-clinical studies such as "Locking Mechanism Strength," "Range of Constraint," "Contact Area and Contact Stress," "Tibiofemoral Range of Motion," "Characterization of UHMWPE Insert Material," "Bacterial Endotoxin Testing," "Shelf Life Studies," "Biocompatibility," and "Wear Testing." These are all tests related to the physical and material properties of the knee implant, not the performance of an AI or algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided document pertains to a physical medical device (knee implant) and not an AI/algorithm.

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