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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

For cemented and un-cemented use.

The E-Poly™ Tibial Bearings are provided in five sizes. Each size comes in five thicknesses. (There are five basic styles of the E-Poly™ Bearings which are intended to be unsel with previously cleared Biomet knee products.)

The E-Poly™ UHMWPE tibial bearings are highly-crosslinked to improve wear resistance, and infused with vitamin E to stabilize free-radicals and prevent oxidative degradation.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device met such criteria. This document is a 510(k) summary for the E-Poly™ Tibial Bearings, which focuses on demonstrating substantial equivalence to legally marketed predicate devices for the purpose of market clearance.

Here's what the document does state:

• Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This generally refers to bench testing for mechanical properties, wear resistance, etc., but specific acceptance criteria or detailed results are not provided.
• Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical studies were performed or submitted for this 510(k) application to establish substantial equivalence.

Therefore, I cannot provide the requested information in the table format or answer the specific questions related to acceptance criteria and performance studies because this data is not present in the provided document.

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