(224 days)
The indications for the sterile Medoff Sliding Plate System vary depending on the configuration of the bone plate. Fracture configurations which lend themselves to the general principle of axial compression should be those that are selected for use with this device. The use of the 4-hole or the 6-hole plating system depends upon surgeon preference and the selection is more related to the size of the surgical exposure and how far down the shaft the fracture extends.
Specific indications for the 135 degree 4-hole standard plate design or 6-hole standard plate design include the following fracture configurations:
- . Basicervical fractures of the femur_
- . Intertrochanteric fractures of the femur.
- . Unstable intertrochanteric fractures of the femur.
- . High subtrochanteric fractures of the femur just distal to the level of the lesser trochanter.
Specific indications for the supracondylar plate design include the following fracture configurations:
- Low transverse or short oblique supracondylar fractures of the distal femur. .
- . T condylar fractures of the femur that can be converted to low transverse or short oblique supracondylar fractures by rigid fixation of condylar fragments with screws.
The sterile Medoff Sliding Plate System includes lag screws, compression screws, locking set screws, and bone plates consisting of a compression slide and a barreled side plate.
This document is a 510(k) summary for a medical device (Medoff Sliding Plate System) and does not contain information about acceptance criteria or a study proving device performance as requested. It describes the device, its indications for use, and materials. It's a regulatory submission, not a clinical study report. Therefore, I cannot provide the requested information based on this input.
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JAN 22 1997
Contact Person: Judy English Date Prepared: January 3, 1997
510(k) Summary
Trade Name: Medoff Sliding Plate System (Sterile) Common Name: Metallic bone fixation device Product Classification: = Predicate Devices: Axial Compression Screw and Hawaiian Supracondylar Plate
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Indications for Use
The sterile Medoff Sliding Plate System includes lag screws, compression screws, locking set screws, and bone plates consisting of a compression slide and a barreled side plate.
The indications for the sterile Medoff Sliding Plate System vary depending on the configuration of the bone plate. Fracture configurations which lend themselves to the general principle of axial compression should be those that are selected for use with this device. The use of the 4-hole or the 6-hole plating system depends upon surgeon preference and the selection is more related to the size of the surgical exposure and how far down the shaft the fracture extends.
Specific indications for the 135 degree 4-hole standard plate design or 6-hole standard plate design include the following fracture configurations:
- . Basicervical fractures of the femur_
- . Intertrochanteric fractures of the femur.
- . Unstable intertrochanteric fractures of the femur.
- . High subtrochanteric fractures of the femur just distal to the level of the lesser trochanter.
Specific indications for the supracondylar plate design include the following fracture configurations:
- Low transverse or short oblique supracondylar fractures of the distal femur. .
- . T condylar fractures of the femur that can be converted to low transverse or short oblique supracondylar fractures by rigid fixation of condylar fragments with screws.
Material
The sterile Medoff Sliding Plate System is manufactured from stainless steel.
000011
N/A