The MAGELLAN™ Intramedullary Femoral Nail System is indicated for use in long bone shaft fractures of the femur which require stabilization of the axis of the bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck fractures, comminuted fractures, segmental fractures, fractures with bone loss, proximal and distal fractures, nonunions and malunions, and bone lengthening.

Device Description

The MAGELLAN™ Magnetic Distal Targeting System is designed to locate and lock in place the distal screw holes of the Magellan Intramedullary Femoral Nail without the use of radiographic equipment. The system includes reamers for preparing the intramedullary canal for nail placement; drill bits to drill screw holes proximally, a targeting compass and magnetic target insert to locate the distal screw holes, and targeting Steinmann pins and drill bits (two sizes) to create the distal screw holes. This instrument system is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.

AI/ML Overview

The provided text is a 510(k) summary for the MAGELLAN™ Magnetic Distal Targeting System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance testing against specific acceptance criteria.

Therefore, the document explicitly states:

"Because the MAGELLAN™ Magnetic Distal Targeting System is substantially equivalent to the predicate device in design, material, and intended use, testing was not performed."

Given this, I cannot provide the information requested in your numbered points as it is not present in the provided text. The device's clearance was based on its substantial equivalence to pre-amendments predicate devices, not on a study proving it met specific acceptance criteria.

Summary

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OCT - 3 1997

Image /page/0/Picture/1 description: The image shows a stylized letter "W" logo. The "W" is formed by three thick, black, downward-pointing triangles arranged side-by-side. The central triangle is slightly offset, creating a visual break in the middle of the "W". A small registered trademark symbol is visible at the bottom right of the logo.

Image /page/0/Picture/2 description: The image shows the logo and contact information for Wright Medical Technology, Inc. The address is 5677 Airline Road, Arlington, TN 38002. The phone number is 901-867-9971.

Contact Person: Date:

Cristie Manuel March 21, 1997

510(k) Summary

Trade/Proprietary Name:

Common Name: Classification: Predicate Device: MAGELLANTM Magnetic Distal Targeting System (proposed name), Product Line Extension Surgical instrument motors and accessories/attachments Class I Preamendments Intramedullary Nail Instrumentation (Wright Medical Technology, Inc.) Russell-Taylor Intramedullary Nail System Instrumentation (Smith and

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

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Description/Indicated Use

The MAGELLANTM Magnetic Distal Targeting System is designed to locate and lock in place the distal screw holes of the Magellan Intramedullary Femoral Nail without the use of radiographic equipment. The system includes reamers for preparing the intramedullary canal for nail placement; drill bits to drill screw holes proximally, a targeting compass and magnetic target insert to locate the distal screw holes, and targeting Steinmann pins and drill bits (two sizes) to create the distal screw holes. This instrument system is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.

The MAGELLANTM Magnetic Distal Targeting System is indicated for use in long bone shaft fractures of the femur which require stabilization of the axis of the bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck fractures, comminuted fractures, segmental fractures, fractures with bone loss, proximal and distal fractures, nonunions and malunions, and bone lengthening.

Testing

Because the MAGELLAN™ Magnetic Distal Targeting System is substantially equivalent to the predicate device in design, material, and intended use, testing was not performed.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 1997

Ms. Kim Tompkins ·Director Clinical and Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K971056 MAGELLAN Maqnetic Distal Trade Name: Targeting System Regulatory Class: II Product Code: HSB Dated: July 3, 1997 Received: July 7, 1997

Dear Ms. Tompkins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Kim Tompkins

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Wright Medical Technology, Inc. MAGELLAN " Magnetic Distal Targeting System

C. Indications for Use of the Device

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MAGELLAN™ Magnetic Distal Targeting System

Indications for Use:

(Please do not write below this line-continue on another page if needed)

水水 * * * * * * 水 Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96) trans

000009

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.