(27 days)
The Genesis II Posterior Stabilized High Flexion Articular Insert is indicated for:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.
The Genesis II Posterior Stabilized High Flexion Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Posterior Stabilized High Flexion Articular Insert is for single use only.
The Genesis II Posterior Stabilized High Flexion Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee System cleared via K030612. The Genesis II Posterior Stabilized High Flexion Articular Insert is for single use only.
The Genesis II Posterior Stabilized High Flexion Articular Inserts are URMWPE tibial components which provide the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibial tray components cleared in K030612.
This document describes the Genesis II Posterior Stabilized High Flexion Articular Insert, a knee implant component.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance Description |
|---|---|
| Mechanical Equivalence | "A review of the mechanical test data indicated that the Genesis II Posterior Stabilized High Flexion Articular Insert is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure." |
| Substantial Equivalence | "The substantial equivalence of the Genesis II Posterior Stabilized High Flexion Articular Insert is based on its similarities in indications for use, design features, operational principles, and material composition" to identified predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "mechanical test data," but it does not specify the sample size used for these tests.
The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention any experts being used to establish a "ground truth" for the mechanical test data. The determination appears to be based on direct mechanical evaluation and comparison to existing devices.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method as this type of study is not applicable to the mechanical testing described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of medical device (knee implant component). The focus is on mechanical and design equivalence, not interpretative tasks.
6. Standalone (Algorithm Only) Performance
A standalone performance study was not done, nor is it applicable as this is a physical medical device, not an algorithm or AI.
7. Type of Ground Truth Used
The ground truth used for the acceptance criteria appears to be:
- Mechanical performance standards/benchmarks: The device's mechanical test data was compared against "expected in vivo loading" and demonstrated equivalence to "devices currently used clinically."
- Predicate device characteristics: Substantial equivalence relies on comparisons in "indications for use, design features, operational principles, and material composition" to existing legally marketed devices.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical knee implant component, not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.