# K962251: Medoff Sliding Plate (Proposed Name)

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 22, 1997 after 224 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Axial Compression Screw: named in the summary without a submission number
- (no number) Hawaiian Supracondylar Plate: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K962251
Methodology: https://510kreport.com/methodology