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K Number
K962251
Device Name
MEDOFF SLIDING PLATE (PROPOSED NAME)
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
1997-01-22

(224 days)

Product Code
KTT
Regulation Number
888.3030
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.
Device Description

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.

AI/ML Overview

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.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.