(70 days)
The AXIOM™ Total Knee System is indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity:
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
The Tibial Tray Plug is intended to be used with all the tibial bases that are available in the AXIOM™ Total Knee System. The purpose of the Tibial Tray Plug is to provide a filler for the screw holes to prevent extrusion of bone cement through the holes when the metal base is implanted without screw fixation. The Tibial Tray Plug will be machined from ultra high molecular weight polyethylene (UHMWPE) conforming to ASTM F 648. The one-piece design will be offered in two alternative slot styles, 4-slotted and 3-slotted.
The Tibial Tray Plug will be offered sterile in a pack of four for insertion into one or more of the four screw holes of the tibial base by the surgeon intraoperatively. The Tibial Tray Plug will also be available preassembled into the tibial tray. Tibial Tray Plugs are placed into the screw holes from the underside of the metal tibial base and snap fit snugly into place. If desired, the Tibial Tray Plug can be removed by using an instrument such as a hemostat to push the plug from the top of the base back through the screw hole.
This document is a 510(k) summary for a medical device called the "Tibial Tray Plug." It provides a description of the device, its indications for use, and a comparison to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy, which are typically found in studies for diagnostic or AI-powered devices.
The document focuses on:
- Device Description: Material (UHMWPE), design (one-piece, 4-slotted and 3-slotted), and how it snaps into the tibial base.
- Intended Use: As a filler for screw holes in total knee arthroplasty to prevent cement extrusion.
- Indications: For use in the AXIOM™ Total Knee System for various knee conditions.
- Comparison to Predicate Devices: Similarities in material, design, availability, and intended use. The only noted difference is the sterilization method (ethylene oxide for the new device vs. gamma radiation for predicates), both achieving a sterility assurance level of 10⁻⁶.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.