Search Results

The Duracon® Posteriorly Stabilizer (PS) Lipped Tibial Inserts are intended to be used with legally marketed Duracon® tibial baseplates and wedges, femoral components, and patellar components as part of a total knee system in primary or revision cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments may or may not be used for revision of a failed prosthesis.

Indications

• Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,
• Rheumatoid arthritis,
• Correction of functional deformity,
• Revision procedures where other treatments or devices have failed,
• Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
• Irreparable fracture of the knee

The Duracon® PS Lipped tibial inserts share the same critical design features as the predicate Duracon® Stabilized tibial inserts. They both have the same snap-fit locking mechanism, augmented by a locking screw, for mating with the current Duracon® tibial baseplates (K915512). The subject Duracon inserts are intended to be used with current Duracon® femoral and patellar components. The subject inserts will be available in the same range of sizes and thicknesses and are manufactured from the same materials as the current Duracon® Stabilized inserts.

The subject inserts have an anterior/posterior (A/P) lipped feature to enhance femoral/tibial implant anterior stability in full extension. In addition, the subject inserts incorporate a patellar cut-out feature to improve patellar tracking.

This document, K012172, is a 510(k) Summary for the Duracon® PS Lipped Tibial Insert. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than presenting novel clinical study data.

Therefore, the provided text does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving those criteria are met.

Here’s why and what can be extracted:

• Acceptance Criteria and Reported Device Performance: The document states, "Mechanical testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts." It does not provide specific quantitative acceptance criteria (e.g., specific thresholds for wear, fatigue strength, range of motion) or the actual results of these tests. It only asserts that the new device shares critical design features and uses the same materials and manufacturing methods as the predicate device.
• Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Mechanical testing." No further details about this testing (e.g., type of tests, parameters, results, sample sizes) are provided.

Therefore, it is not possible to complete the requested table and answer many of the questions based on the provided text.

However, I can extract the general nature of the evidence and the claim made:

Summary of Device Performance Evidence (Based on available information):

• Claim: The Duracon® PS Lipped Tibial Inserts are substantially equivalent to the predicate Duracon® Stabilized Tibial Inserts (K932070 and K936292).
• Evidence Type: Mechanical testing.
• Rationale for Equivalence:
  • Shared critical design features (snap-fit locking mechanism, augmented by a locking screw).
  • Intended use is identical.
  • Available in the same range of sizes and thicknesses.
  • Manufactured from the same materials.
  • Fundamental scientific technology, basic design concepts, and manufacturing methods have not changed.

Unable to Extract from the Provided Text:

• Specific Acceptance Criteria: Not detailed.
• Specific Reported Device Performance: Not detailed beyond the assertion of substantial equivalence.
• Sample size used for the test set: Not mentioned.
• Data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for mechanical testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is a medical device, not an AI diagnostic tool).
• If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for mechanical testing.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In essence, this document is a regulatory submission demonstrating substantial equivalence based on design, materials, and mechanical testing that supports that equivalence, rather than a detailed report of a clinical study or specific acceptance criteria for performance.

Ask a specific question about this device