(165 days)
The Duracon® CS (Condylar Stabilizing) Tibial Inserts are intended to be used with Duracon® Universal and Cruciform tibial baseplates, Duracon® Cruciate Retaining femoral components and Duracon® patellar components as part of a total knee system in primary 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 should be intact if this insert is utilized. Because this insert does not incorporate a support post, it can accommodate the posterior cruciate ligament if it is present. More specific indications/contraindications are listed below:
Indications
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic I arthritis or avascular necrosis,
- Rheumatoid arthritis,
- 비 Correction of functional deformity,
- Post-traumatic loss of joint anatomy, particularly when there is patello-femoral 미 erosion, dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee
The subject Duracon® CS Tibial Insert is an ultra-high molecular weight polyethylene tibial insert designed to be used with the femoral, tibial, and patellar components of the Duracon® Total Knee System. This insert is available in small, medium, large, and extralarge sizes in the following thicknesses: 9mm, 11mm, 16m, 19mm, 22mm, and 25mm. The subject insert has a dished articulating surface geometry to provide anatomic rollback, flexion-extension and internal-external rotation. The subject tibial insert features a raised anterior eminence designed to provide greater anterior constraint in situations where the posterior cruciate ligament is not present or not functional. This anterior eminence is designed to provide substitution for the posterior cruciate ligament if it is not present or cannot be preserved. The subject insert provides approximately 37 percent more constraint than the predicate Duracon® AP Lipped Tibial Insert, without any increase in rotational constraint.
The subject insert does not feature a support post. This allows the Duracon® Condylar Stabilizing (CS) Lipped Tibial Insert to be used with the Duracon® Condylar Femoral Components. These condylar femoral components do not require the removal of additional bone from the distal surface of the femur. Because this insert does not feature a support post, it may also be used in situations where the posterior cruciate ligament is present. The geometry of the insert will accommodate the PCL if it is present.
The subject Duracon® CS Tibial Insert features the same locking mechanism as the previously released Duracon® Condylar and AP Lipped Tibial Insert.
The provided text describes a 510(k) premarket notification for a medical device, the Duracon® CS Lipped Tibial Insert. It does not contain information about a study proving the device meets acceptance criteria. The document is primarily a regulatory submission outlining the device's identification, indications, contraindications, and design features, along with the FDA's decision regarding its substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the given text.
The information requested, such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, are all related to a clinical study or performance evaluation, which is not present in this regulatory document.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.