(21 days)
The Klassic® Knee System is intended for prosthetic replacement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur with Cobalt 3D®, and the Klassic® Tibial Baseplate with Ti-Coat® which are indicated for cementless use.
The purpose of this Special 510(k) is to add the Klassic® Tibial Inserts, PS-Max®, an additional posterior stabilizing design option, to the Klassic® Knee System (K112906). The Klassic® Tibial Inserts, PS-Max® are available in various sizes and thicknesses to match patient anatomy and provide surgical options.
This submission describes the Klassic® Knee System Tibial Inserts, PS-Max®, a medical device intended for prosthetic replacement in knee arthroplasty. The submission is a Special 510(k), meaning it aims to add a new design option to an already cleared Klassic® Knee System (K112906). The primary goal is to demonstrate substantial equivalence to a predicate device, the Klassic® Tibial Inserts, PS-Post™ (K183596).
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the subject device met pre-determined acceptance criteria for various verification activities. However, it does not explicitly list the quantitative acceptance criteria or the specific reported device performance values in a table format within the provided text. It generally states that the device "met the pre-determined acceptance criteria" and that "the results of analysis and testing indicate that the subject tibial inserts are substantially equivalent to the predicate components."
The types of tests performed indicate the areas for which performance criteria would have been established:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Femoral/Tibial Stability Characteristics | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Contact Stress Evaluation | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Range of Motion | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Knee Simulator Wear | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Tibial Insert Post Strength and Fatigue | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Tibial Insert Modular Disassembly | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Compliance with LAL requirements for orthopedic implants | "in compliance with LAL requirements for orthopedic implants." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance. It only mentions "Bench testing and engineering analysis were performed." This implies laboratory-based testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study appears to be engineering and bench testing, not involving human expert assessment of a test set for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. The study focused on bench testing, which doesn't typically involve adjudication in the clinical sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes bench testing and engineering analysis, not a clinical MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This question is not directly applicable as the device is a physical knee implant component, not a software algorithm. The "standalone" performance here refers to the physical properties of the insert as tested in a lab, separate from human implantation. The bench tests performed are essentially the "standalone" evaluation of the device's physical and mechanical characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this type of device (physical implant) is established by engineering specifications, industry standards (e.g., LAL requirements), and comparative performance with a legally marketed predicate device. The tests performed (stability, contact stress, range of motion, wear, strength, fatigue, modular disassembly) are designed to assess these physical and mechanical properties against pre-defined engineering targets and the performance of the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not a machine learning or AI device that requires a "training set."
§ 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.