(48 days)
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.
The Triathlon Tritanium Tibial Baseplate and Tritanium Metal-Backed Patella components are indicated for both uncemented and cemented use.
The Triathlon Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
- Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.
- Severe anteroposterior instability of the knee joint.
Additional Indications for Total Stabilizer (TS) Components:
- Severe instability of the knee secondary to compromised collateral ligament integrity or function.
Indications for Bone Augments:
- Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied bone loss.
Additional Indications for Cone Augments
- Severe degeneration or trauma requiring extensive resection and replacement
- Femoral and tibial bone voids
- Metaphyseal reconstruction
The Triathlon Tritanium® Cone Augments are intended for cemented or cemented or cementless use.
The Triathlon® Posterior Stabilized (PS) Femoral Component - beaded with Peri-Apatite (PA) and Triathlon® Cruciate Retaining (CR) Femoral Component - beaded with Peri-Apatite (PA) are components of the Triathlon® Total Knee System previously cleared via 510(k)s K051380, K141056 and K172326. The subject Triathlon® Femoral Components are components of the Triathlon® Total Knee System and are used in total knee arthroplasty procedures. The subject Triathlon® Femoral Components are available in 8 different sizes and in left and right configurations that are anatomically suited to the left or right knee. The subject Triathlon® Femoral Components are manufactured from cast cobalt-chrome-molybdenum alloy (ASTM F75) with a cobalt-chrome-molybdenum alloy (ASTM F75) double layer porous coating (beading) on the femoral fixation surface. Additionally, the subject Triathlon® Femoral Components are coated with Peri-Apatite (ASTM F1185).
The design and materials of the subject Triathlon® Femoral Components are identical to the predicate Triathlon® Femoral Components cleared via 510(k)s K051380, K141056 and K172326. The proposed modification is to introduce automated equipment for the first and second porous coating (beading) application process steps for the subject Triathlon® Femoral Components. There are no modifications proposed to the other components of the Triathlon® Total Knee System previously cleared via 510(k)s K051380, K141056 and K172326. The subject Triathlon® Femoral Components will have the same performance specifications as the predicate Triathlon® Femoral Components cleared via 510(k)s K051380, K141056 and K172326.
This document describes the Stryker Corporation's 510(k) submission for the Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite and Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite. The submission, K200782, aims to demonstrate substantial equivalence to previously cleared devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices and the performance of non-clinical testing. The device is considered to meet these criteria if it demonstrates "substantial equivalence" and the proposed modification does not affect safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in intended use | The subject Triathlon Femoral Components have the same intended use as the predicate Triathlon Femoral Components. |
| Substantial equivalence in indications for use | The subject Triathlon Femoral Components have the same Indications for Use as the predicate Triathlon Femoral Components. |
| Substantial equivalence in design | The design of the subject Triathlon Femoral Components is identical to the predicate Triathlon Femoral Components. The proposed modification is to introduce automated equipment for the porous coating application, not a design change of the component itself. |
| Substantial equivalence in materials | The materials of the subject Triathlon Femoral Components are identical to the predicate Triathlon Femoral Components (cast cobalt-chrome-molybdenum alloy (ASTM F75) with a cobalt-chrome-molybdenum alloy (ASTM F75) double layer porous coating, coated with Peri-Apatite). |
| Substantial equivalence in performance characteristics | The subject Triathlon Femoral Components will have the same performance specifications as the predicate Triathlon Femoral Components. Non-clinical testing for porous coating type (beaded, sintered cobalt-chrome coatings) showed substantial equivalence. |
| Substantial equivalence in operational principles | Not explicitly detailed, but implied by the overall statement of substantial equivalence. |
| Proposed modification does not affect safety or effectiveness | Non-clinical testing for porous coating type (beaded, sintered cobalt-chrome coatings) demonstrated that the proposed modification does not affect safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size in the context of a test set for clinical performance. The evaluation conducted here is primarily non-clinical, focusing on the comparison of an updated manufacturing process against existing devices.
- Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" consists of the subject Triathlon Femoral Components undergoing non-clinical testing.
- Data Provenance: The testing was non-clinical laboratory testing. No geographical or temporal (retrospective/prospective) information is provided as it's not human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on non-clinical testing for performance characteristics, specifically for the porous coating process. The "ground truth" is established through physical and material science testing standards, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation is based on non-clinical laboratory testing, not a human reader assessment requiring adjudication.
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 submission for an orthopedic implant (knee femoral component), not an AI-powered diagnostic or assistive device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The "performance" being evaluated is the physical and material characteristics of a medical implant after a manufacturing process change.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for proving the device meets acceptance criteria is based on non-clinical laboratory testing standards and direct comparison of material properties and design to legally marketed predicate devices. Specifically, it mentions "Testing for porous coating type a. beaded, sintered cobalt-chrome coatings on a cobalt-chrome substrate as per FDA guidance document, 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,' dated April 28, 1994."
8. The Sample Size for the Training Set
Not applicable. Since there's no clinical study or AI algorithm involved, there is no "training set" in the context of this submission. The device is a physical implant.
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no training set.
§ 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.