(64 days)
The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthrilis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
The Revision Femoral Knee Components are manufactured from Oxinium. Wedges and screws are also included in the Revision Knee System. The devices are based upon existing components of the Genesis II Total Knee System.
This is a medical device submission (510(k)) for a Revision Knee System. These submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting de novo clinical studies with acceptance criteria and performance metrics in the way that an AI/software device would.
Therefore, the provided document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device performance study.
Instead, the document focuses on:
- Intended Use: Similar to predicate device (Genesis II Constrained Knee System).
- Device Description: Manufactured from Oxinium, based on existing components of the Genesis II Total Knee System.
- Substantial Equivalence Information: The device (Revision Knee System) is substantially equivalent to existing components of the Genesis II Total Knee System due to similarities in design features, overall indications, and material composition.
- Technological Comparison: Intended use, designs, and materials are substantially equivalent to predicate components. Mentions "Design Control Activities have been completed and the results indicate that the subject devices meet the requirements of the applicable FDA guidance documents," but no specific performance data or acceptance criteria are provided in the public summary.
In summary, this document describes a traditional medical device (knee implant) and its regulatory clearance process based on substantial equivalence, not a software/AI device that would typically have the requested data points.
§ 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.