(95 days)
The Triathlon® Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® Total Knee System is intended for cementless use only.
Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory . 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.
Additional Indications for Posterior Stabilized Components:
- Ligamentous instability requiring implant bearing surface geometries with . increased constraint.
- Absent or non-functioning posterior cruciate ligament. .
The Triathlon® Total Knee System beaded and beaded with Peri-apatite components are intended for uncemented use only.
The Triathlon® Total Knee System will be available with femoral and tibial components in a cementless design with and without Stryker Howmedica Osteonics' Peri-apatite (PA) coating. The Triathlon® fixed bearing cementless baseplate and femoral components are compatible with the current Triathlon® tibial inserts and patellas. The Triathlon® components proposed in this submission are manufactured from cast cobalt chrome and have a cobalt chrome porous coating, available with and without a PA coating. The Triathlon® tibial component is fixed bearing and will be provided in sizes 1 through 8. The femoral components will be offered in both cruciate retaining (CR) and posterior stabilizing (PS) versions, also in sizes 1 through 8.
This is a medical device 510(k) summary for the Triathlon® Total Knee System. It details the device's identity, indications for use, and a declaration of substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Device Performance:
This document does not present acceptance criteria or a study proving the device meets them in the way a diagnostic AI would. Instead, it is a Premarket Notification (510(k)) summary, which is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device.
For a medical device like a total knee replacement system, "acceptance criteria" are typically met through adherence to established consensus standards (e.g., ISO standards for biomechanical testing, material biocompatibility), design and manufacturing controls, and clinical performance data that has been gathered on the predicate devices over time.
Instead of a table of acceptance criteria and reported device performance in the context of an AI study, the relevant information for this 510(k) is:
| Criterion Type | Description |
|---|---|
| Intended Use | The Triathlon® Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. |
| Indications for Use | Painful, disabling joint disease of the knee from noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), rheumatoid arthritis; post-traumatic loss of knee joint configuration and function; moderate varus, valgus, or flexion deformity where ligamentous structures can be returned to function/stability; revision of previous unsuccessful knee replacement; fracture of distal femur/proximal tibia not stabilizable by standard techniques. Additional indications for PS components: ligamentous instability requiring increased constraint, absent/non-functioning PCL. |
| Substantial Equivalence | Based on similarities in intended use, design, and sterilization to predicate devices: Howmedica Osteonics' Triathlon® PS Total Knee System (K042993), Triathlon® CR Total Knee System (K040267), Duracon® Total Knee System (K032163, K032418). (Predicate device information is in Appendix D, not provided here). |
| Device Design/Materials | Femoral and tibial components available in cementless design, with/without Peri-apatite (PA) coating. Fixed bearing cementless baseplate and femoral components compatible with current Triathlon® tibial inserts and patellas. Manufactured from cast cobalt chrome with a cobalt chrome porous coating, with/without PA coating. Tibial component is fixed bearing, sizes 1-8. Femoral components in CR and PS versions, sizes 1-8. |
Information Not Applicable or Not Provided in this Document for AI/Diagnostic Studies:
The following points are typically relevant for AI/diagnostic device studies, but are not applicable or not provided in this 510(k) summary for a knee implant:
- Sample size used for the test set and the data provenance: This document does not describe a "test set" in the context of an AI or diagnostic study. The "testing" for this orthopedic implant would involve biomechanical bench testing, materials characterization, and potentially clinical experience with the predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant is clinical outcome, successful integration, and long-term function, established through clinical follow-up, not expert image review.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI diagnostic device.
- 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): For an implant, ground truth would be real-world clinical outcomes (e.g., pain relief, restoration of function, implant survival, absence of complications) over time. This 510(k) relies on the established safety and effectiveness of the predicate devices.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) document is a regulatory submission demonstrating substantial equivalence for an orthopedic implant, not a study reporting on the performance of a diagnostic or AI device. The "proof" of meeting acceptance criteria lies in its substantial equivalence to already legally marketed devices, which have a history of safe and effective use.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.