(116 days)
The Triathlon® Screw-fixation tibial baseplates are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All total knee components presented in this submission are provided sterile for single-use.
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic 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 (PS) Components:
- Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.
The Triathlon® Screw-fixation Tibial Baseplates are intended for cementless use only.
The tibial baseplates of the Triathlon® Total Knee System has been modified to include a screwfixation option for use with existing Triathlon® Total Knee components. The subject tibial baseplate is porous coated and will be available with and without Howmedica Osteonics' Periapatite (PA) coating. The Triathlon® fixed bearing cementless tibial baseplates are compatible with Triathlon® CR, PS, and CS tibial inserts and patellae. 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 peri-apatitie coating. The Triathlon® tibial component is fixed bearing and will be provided in sizes 1 through 8. Compatible cobalt chrome bone screws are also included in this submission in 6.5mm diameter with lengths of 16mm, and 20mm to 60mm in 5mm increments.
This 510(k) submission (K072575) describes a modification to an existing device, the Triathlon® Total Knee System, specifically a screw-fixation option for its tibial baseplate. The submission asserts substantial equivalence to previously cleared devices rather than providing a study demonstrating performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding a "study that proves the device meets the acceptance criteria" in the context of device performance metrics (like sensitivity, specificity, etc., which are common for AI/diagnostic devices) is not directly applicable here.
However, we can reframe the request to address the acceptance criteria for substantial equivalence and how the provided information supports that.
1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Characteristics
For a substantial equivalence claim, the "acceptance criteria" are the characteristics of the predicate device, and the "reported device performance" refers to how the new device's characteristics compare to those predicates.
| Acceptance Criteria (Predicate Device Characteristics) | Reported Device Performance (Triathlon® Screw-fixation Tibial Baseplate) |
|---|---|
| Intended Use: Primary and revision total knee arthroplasty to alleviate pain and restore function. | Intended Use: Same as predicate. (Primary & revision TKA for pain relief & function restoration). |
| Indications for Use: (e.g., Painful/disabling joint disease, post-traumatic loss of configuration, moderate deformity, revision, specific fracture types, ligamentous instability for PS components). | Indications for Use: Same as predicate. All general and PS component specific indications are identical. |
| Material: Cast cobalt chrome components, cobalt chrome porous coating (with/without Peri-apatite coating). | Material: Same as predicate. Cast cobalt chrome components, cobalt chrome porous coating (with/without Peri-apatite coating). |
| Design: Tibial baseplate compatible with Triathlon® CR, PS, and CS tibial inserts and patellae. Fixed bearing. | Design: Modified tibial baseplate to include screw-fixation option for use with existing Triathlon® Total Knee components. Fixed bearing. Compatible with same inserts/patellae. |
| Sterilization: Provided sterile for single-use. | Sterilization: Same as predicate. Provided sterile for single-use. |
| Fixation Method: Cementless use. | Fixation Method: Cementless use only. (New screw-fixation is an additional cementless option). |
| Sizes: Available in sizes 1 through 8. | Sizes: Available in sizes 1 through 8. |
| Additional Components (Predicates): (e.g., Howmedica Osteonics' Triathlon® Total Knee System, Duracon® Total Knee System components). | Additional Components (New): Compatible cobalt chrome bone screws (6.5mm diameter, 16mm, and 20mm-60mm in 5mm increments). |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable for this type of submission. This 510(k) is for a device modification and relies on a demonstration of substantial equivalence to previously cleared predicate devices through direct comparison of design, materials, and intended use, rather than a clinical trial or performance study with a "test set" in the context of diagnostic or AI devices. The "data provenance" would refer to the characteristics of the predicate devices themselves, which are established through their own prior 510(k) clearances.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no "test set" in the sense of patient data requiring expert consensus for ground truth. The "ground truth" for substantial equivalence is the prior FDA clearance of the predicate devices, which implies FDA's expert review and acceptance of their safety and effectiveness.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication by experts was used.
5. 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 implant device, not a diagnostic or AI-powered device where an MRMC study would typically be performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the FDA clearance of the predicate devices. The new device's safety and effectiveness are established by demonstrating that its design, materials, intended use, and performance are substantially equivalent to those already-cleared devices, meaning it raises no new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for physical implant device modifications in the same way there would be for an AI algorithm. The "training" for the design and manufacturing of such a device is based on established engineering principles, biomechanical testing, and historical clinical performance of similar devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there isn't a "training set" in the AI sense. The "ground truth" for the development of such devices is based on established biomechanical and clinical requirements for knee arthroplasty, derived from decades of orthopedic research, clinical experience, and regulatory standards. For the screw-fixation option, the ground truth would also include the established performance and safety of the existing Triathlon® Total Knee System and similar screw-fixation designs in other cleared devices.
§ 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.