(70 days)
MGII tibial tray plug
Not Found
No
The description focuses on the mechanical components and materials of a knee implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The AXIOM™ Total Knee System, which includes the Tibial Tray Plug, is indicated for reducing or relieving pain and/or improving knee function in patients with various degenerative joint conditions, functional deformities, and fractures. These are therapeutic outcomes.
No
Explanation: The device is a component of a total knee arthroplasty system (Tibial Tray Plug) which is used for treatment and correction of functional deformities, not for diagnosis.
No
The device description clearly states the device is a physical component (Tibial Tray Plug) made of UHMWPE, intended for surgical implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The AXIOM™ Total Knee System and its component, the Tibial Tray Plug, are surgical implants used inside the body during a total knee replacement procedure. They are designed to replace damaged joint structures and improve function.
- Intended Use: The intended use clearly states it's for total knee arthroplasty to address conditions like osteoarthritis and rheumatoid arthritis, and for revision procedures. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant used in a surgical procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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 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:
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- revision procedures where other treatments or devices have failed; and
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- treatment of fractures that are unmanageable using other techniques.
Product codes
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Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeon intraoperatively
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis, Tibial Tray PMMA Plug, Wright Medical Technology, Inc., MGII tibial tray plug, Zimmer, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the number K961900 at the top left corner. Below the number is the date JUL 25 1996. To the right of the date is the Wright Medical Technology logo and company name. The address 5677 Airline Road, Arlington, TN 38002 is listed below the company name.
510(k) Summarv
Contact Person: Kim Tompkins Date Prepared: May 15, 1996
Trade/Common Name: Tibial Trav Plug Classification Name: Predicate Devices:
Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. Tibial Tray PMMA Plug, Wright Medical Technology, Inc. MGII tibial tray plug, Zimmer, Inc.
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Description
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.
Indications
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.
Summarv of differences
The Tibial Tray Plug is similar to either of the two predicate devices with respect to material, design, availability, and intended use. The only difference left between the Tibial Tray Plug and both predicate devices is the sterilization method. The predicate devices are sterilized with gamma radiation and the Tibial Tray Pluq will be sterilized with ethylene oxide, both well accepted for achieving a sterility assurance level of 10°.
000128