(373 days)
The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:
- malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement:
- revision cases for a failed previous prosthesis requiring extensive resection and replacement;
- severe trauma requiring extensive resection and replacement.
The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The subject DePuy LPS Distal Femoral Component is a modular component that is designed to replace the distal portion of the femur. Unlike primary knee systems, the LPS System is used when the amount of bone resection and replacement is extreme (e.g. in oncology cases or endstage revision).
The LPS Distal Femoral Component is manufactured from cobalt-chromemolybdenum alloy and is available in two sizes, X-small low profile and XX-small, both in left and right configurations. The surface has a highly polished mirror finish for smooth articulation with the polyethylene component of the tibial plateau/hinge assembly and the resurfaced patella.
This document is a 510(k) summary for a medical device called the "DePuy LPS Distal Femoral Component." It describes the device's intended use, indications for use, and establishes its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing.
Therefore, I cannot provide a detailed response to your request, as the information you are asking for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, etc.) is not present in the provided text.
This 510(k) submission focuses on demonstrating the new device's substantial equivalence to existing devices based on design, materials, packaging, and sterilization, rather than presenting original clinical or performance study data with specific acceptance criteria.
§ 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.