Search Results

The Implex Continuum Knee Unity Tibial Component is indicated for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.

The Implex Continuum Knee Unity Tibial Component, Cemented, is available in 8 thickness sizes from 10 mm to 22 mm, in 2 mm increments, and a 26 mm option; and A-P dimensions from 41 mm to 57 mm, and M-L dimensions from 62 mm to 89 mm. The Implex CK Unity Tibial Component is comprised of Hedrocel porous tantalum and UHMWPE. The CK Unity Tibial component is offered in two fixation post options; option A with hexagonal Hedrocel® posts, and option B with polyethylene fixation pegs. The CK Unity Tibial Component is to be implanted using the Implex Continuum Knee System Instrumentation and Surgical Protocol.

The provided document is a 510(k) summary for the Implex Continuum Knee Unity Tibial Component, Cemented. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study outlining specific acceptance criteria and performance of a novel device.

Therefore, this document does not contain the information requested to complete the table and answer the study-related questions.

The "Performance Data" section explicitly states: "Previous testing of the predicate devices and associated materials are sufficient for substantial equivalence determination. The relevant data is found in Master File MAF #920 and K964509." This indicates that the 510(k) relies on pre-existing data from previously approved devices, rather than a new study specific to this particular device's performance against defined acceptance criteria.

Without access to Master File MAF #920 and K964509, it is impossible to extract the details about specific acceptance criteria and device performance.

Ask a specific question about this device