STERILE KIRSCHNER WIRES AND STEINMANN PINS

K960385 · Depuy, Inc. · HTY · Mar 27, 1996 · Orthopedic

Device Facts

• Record ID: K960385
• Device Name: STERILE KIRSCHNER WIRES AND STEINMANN PINS
• Applicant: Depuy, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Mar 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterile Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Device Story

Sterile Kirschner wires (K-wires) and Steinmann pins; used for bone fracture fixation, reconstruction, guide pins, or skeletal traction. Manufactured from 316 LVM stainless steel; lengths 4-9 inches; diameters 0.028-0.188 inches. Point styles include trocar, bayonet, double end trocar, and double end bayonet. Used by surgeons in clinical/OR settings. Provides mechanical stabilization of bone segments; facilitates surgical procedures through percutaneous insertion.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence based on design, material, and intended use similarity to legally marketed predicate.

Technological Characteristics

Material: 316 LVM stainless steel. Form factor: Smooth or threaded wires/pins; 4-9 inch length; 0.028-0.188 inch diameter. Point styles: Trocar, bayonet, double end trocar, double end bayonet. Mechanical fixation device.

Indications for Use

Indicated for patients requiring bone fracture fixation, bone reconstruction, guide pins for implant insertion, or skeletal traction via percutaneous implantation.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• DePuy Non-sterile Kirschner Wires and Steinmann Pins

Submission Summary (Full Text)

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K960385

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM: DePuy Inc.
700 Orthopaedic Drive MAR 27 1996
Warsaw, Indiana 46581-0988

510(K) CONTACT: Cheryl Hastings
Manager, Pre-clinical Device Evaluation

TRADE NAME: Sterile Kirschner Wires and Steinmann Pins

COMMON NAME: Bone Fixation Fasteners

CLASSIFICATION: 888.3040 Smooth or threaded bone fixation fasteners

DEVICE PRODUCT CODE: 87 HTY and 87 JDW

SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Non-sterile Kirschner Wires and Steinmann Pins

INTENDED USE AND DEVICE DESCRIPTION:
The Sterile Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

This system consists of sterile, smooth and threaded Kirschner wires (K-wires) and Steinmann pins ranging in length from 4 to 9 inches and ranging in diameter from 0.028 to 0.188 inches. All of the K-wires and Steinmann pins except the 6" K-wires are available with four point style options: trocar, bayonet, double end trocar and double end bayonet. The 6" K-wires are available with double end trocar points. All of the K-wires and Steinmann pins are manufactured from 316 LVM stainless steel.

BASIS OF SUBSTANTIAL EQUIVALENCE:
A comparison of the sterile K-wires and Steinmann pins described in this submission and the non-sterile devices sold prior to 1976 shows that they are very similar or identical in terms of design, sizes, material and intended use. The only significant difference between the two systems is that the system described in this submission is provided sterile while the system sold by DePuy prior to 1976 was non-sterile.

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