MEDOFF SLIDING PLATE (PROPOSED NAME)

K962251 · Wrightmedicaltechnologyinc · KTT · Jan 22, 1997 · Orthopedic

Device Facts

• Record ID: K962251
• Device Name: MEDOFF SLIDING PLATE (PROPOSED NAME)
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KTT · Orthopedic
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Metallic bone fixation system; includes lag screws, compression screws, locking set screws, and bone plates with compression slide and barreled side plate. Used by surgeons in clinical settings for internal fixation of femoral fractures. Device applies principle of axial compression to stabilize fracture sites. Surgeon selects plate configuration (4-hole or 6-hole) based on fracture extent and surgical exposure. Provides rigid fixation to facilitate bone healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manufactured from stainless steel. System comprises lag screws, compression screws, locking set screws, and bone plates with compression slide and barreled side plate. Mechanical fixation device.

Indications for Use

Indicated for patients with femoral fractures requiring axial compression, specifically basicervical, intertrochanteric, unstable intertrochanteric, and high subtrochanteric femoral fractures (standard plate designs), or low transverse, short oblique, and T-condylar supracondylar fractures of the distal femur (supracondylar plate design).

Regulatory Classification

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.

Predicate Devices

• Axial Compression Screw
• Hawaiian Supracondylar Plate

Submission Summary (Full Text)

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JAN 22 1997
K962251

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: II
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.

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