(35 days)
The intended use of the size one Triathlon™ Cruciate Retaining Tibial Insert is the same as that of the predicate device described in premarket notification K040267 – it is intended for use with Triathlon™ Cruciate Retaining femoral components, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. The cruciate retaining design is intended to accommodate the posterior cruciate ligament if it is present.
Indications:
- · Painful, disabling joint disease of the knee resulting from: nonimflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid 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.
This premarket notification describes a smaller size of Triathlon™ Cruciate Retaining Tibial Insert. This smaller size insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ CR Femoral component in primary or revision total knee arthroplasty. This size I tibial insert has smaller anterior-posterior and medio-lateral dimensions than the size 2 predicate.
This document is a Special 510(k) Premarket Notification for a new size of a previously cleared device. It primarily focuses on demonstrating substantial equivalence to the predicate device and does not contain information about acceptance criteria, efficacy studies, or performance benchmarks as would be found in a clinical trial report.
Therefore, the requested information cannot be extracted from the provided text. The document is a regulatory submission for a Class II medical device, which often relies on demonstrating equivalence rather than comprehensive clinical performance studies to the extent that a new drug or high-risk device might.
Specifically, the document does NOT contain the following information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone algorithm performance study.
- Type of ground truth used for performance evaluation.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document states: "This premarket notification describes a smaller size of Triathlon™ Cruciate Retaining Tibial Insert. This smaller size insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ CR Femoral component in primary or revision total knee arthroplasty." It then lists the intended use, which is identical to the predicate device. This confirms that the submission is for a minor modification (new size) to an existing, cleared device, and thus leverages the predicate's established safety and effectiveness. Studies demonstrating performance against acceptance criteria are typically not required for such modifications; rather, the focus is on showing that the new size does not introduce new safety or efficacy concerns compared to the predicate.
§ 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.