(96 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 Tritaium® Metal-Backed Patella components are indicated for both uncemented and cemented use.
The Triathion® 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 by bone loss.
The Triathlon® Tritanium® Metal-Backed Patella is an extension of the Triathlon® Total Knee System product line for use in primary and revision Total Knee Arthroplasty. It is a sterile, single-use, non-modular metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in symmetric and asymmetric designs that are available in multiple sizes. The metalbacking features a porous-coated posterior surface and three porous-coated pegs to provide cemented or cementless fixation to bone.
This document, a 510(k) Summary for the Triathlon® Tritanium® Metal-Backed Patella, focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of a device meeting specific acceptance criteria through performance data. Therefore, many of the requested elements for describing an acceptance criteria study are not present in this submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria with corresponding device performance metrics in the typical sense of a clinical or analytical performance study. Instead, it lists non-clinical laboratory tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" in this context is the successful completion of these tests, implying that the new device performs comparably to the predicates.
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance |
|---|---|
| Material Properties: | |
| Elemental Composition (ASTM E1941, E1447, E1409) | Tested and found comparable to predicates |
| Metallurgical & Morphological Properties (ASTM E112, F1854) | Tested and found comparable to predicates |
| Mechanical Properties (ASTM F1147, F1044, F1160, E8) | Tested and found comparable to predicates |
| Plastic Deformation of Porosity (ASTM F1854) | Tested and found comparable to predicates |
| Mechanical Performance: | |
| Static Tensile Bond Strength of UHMWPE/Metal Interface | Tested and found comparable to predicates |
| Static Peg Shear Strength | Tested and found comparable to predicates |
| Patello-Femoral Contact Stress/Contact Area | Tested and found comparable to predicates |
| Malaligned Endurance Testing | Tested and found comparable to predicates |
| Patellar Subluxation Testing | Tested and found comparable to predicates |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. For non-clinical laboratory testing, the sample size typically refers to the number of test articles (patellar components) subjected to each specific test. This tends to be much smaller than clinical study sample sizes and is dependent on the specific ASTM standard or internal protocol used.
- Data Provenance: The tests are non-clinical laboratory tests, likely conducted by the manufacturer (Stryker Orthopaedics) or a contract laboratory. The "country of origin of the data" would typically be the location of the testing facility, which is not specified but presumed to be a regulated environment. The data is retrospective in the sense that these are engineering and material characterization tests performed on manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as this submission is for a medical device and relies on engineering and material testing standards (ASTM) to demonstrate substantial equivalence, not on expert ground truth for an AI or diagnostic device.
4. Adjudication Method for the Test Set
This is not applicable. The "test set" here refers to physical components undergoing laboratory testing, not, for example, medical images requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic or AI-assisted devices to assess human reader performance. This submission is for a physical orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This concept applies to AI/software as a medical device, which this orthopedic implant is not.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the established engineering and material specifications, as well as the performance characteristics of the predicate devices. The new device is tested against these benchmarks (often defined by ASTM standards) to show that its properties are within acceptable ranges and comparable to the predicates.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an orthopedic implant submission based on substantial equivalence through non-clinical testing. This term is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
§ 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.