MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM

K971135 · Wrightmedicaltechnologyinc · HSB · Jun 5, 1997 · Orthopedic

Device Facts

• Record ID: K971135
• Device Name: MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSB · Orthopedic
• Decision Date: Jun 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Modular intramedullary fixation system for femoral fractures; includes nails, rod inserts, caps, locking screws, and instrumentation. Features magnetic distal targeting system to locate/lock distal screw holes without radiographic equipment. Components: reamers, targeting compass, magnetic target insert, Steinmann pins, drill bits. Used in surgical settings by orthopedic surgeons. Magnetic targeting system facilitates screw placement, reducing reliance on intraoperative fluoroscopy. System provides mechanical stabilization of femoral fractures to promote healing.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and theoretical analysis of mechanical strength.

Technological Characteristics

Constructed of 316 LVM stainless steel (ASTM F 138). Modular system includes femoral nails, inserts, caps, and locking screws. Features magnetic distal targeting instrumentation (compass and magnetic insert) for screw hole localization. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients with femoral long bone shaft fractures requiring stabilization, including subtrochanteric, intertrochanteric, femoral neck, comminuted, segmental, proximal/distal fractures, bone loss, nonunions, malunions, and bone lengthening.

Regulatory Classification

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.

Predicate Devices

• MAGELLAN™ Femoral Nail (Wright Medical Technology, Inc.)
• Russell-Taylor Femoral Nail System (Smith and Nephew)

Submission Summary (Full Text)

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K971135
JUN - 5 1997


# WRIGHT
## MEDICAL TECHNOLOGY, INC.
### 5677 AIRLINE ROAD
### ARLINGTON, TN 38002
### 901-867-9971

Contact Person: Cristie Manuel
Date: March 26, 1997

## 510(k) Summary

| Trade/Proprietary Name: | MAGELLAN™ Intramedullary Nail System |
| --- | --- |
| Common Name: | Intramedullary Fixation Rod and Accessories |
| Classification: | Class II |
| Predicate Device: | MAGELLAN™ Femoral Nail manufactured by Wright Medical Technology, Inc. and the Russell-Taylor Femoral Nail System manufactured by Smith and Nephew |

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

## Description/Indicated Use

The MAGELLAN™ Intramedullary Femoral Nail System is a modular system consisting of femoral nails, femoral rod inserts, nail caps, locking screws, and instrumentation for fixation. The system is made of 316 LVM stainless steel conforming to ASTM F 138. The nail is available in six outer diameters and eight lengths. The nail may be cross-locked dynamically or statically, locked antegrade, and also has reconstruction capabilities.

This MAGELLAN™ Magnetic distal targeting instrumentation 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; a targeting compass and magnetic target insert that locate the distal screw holes, and targeting Steinmann pins and drill bits (two sizes) that create the proximal and 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 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.

## Testing

Testing and theoretical data show that the MAGELLAN™ nail device has appropriate strength for clinical usage, and will perform similarly to the Russell-Taylor System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 5 1997

Ms. Cristie Manuel
Regulatory Affairs Associate
Wright Medical Technology, Inc.
5677 Airline Road
Arlington, Tennessee 38002

Re: K971135
MAGELLAN™ Intramedullary Femoral Nail System
Regulatory Class: II
Product Code: HSB
Dated: March 26, 1997
Received: March 27, 1997

Dear Ms. Manuel:

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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. Cristie Manuel

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 legally 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Premarket Notification
Wright Medical Technology, Inc.
MAGELLAN™ Intramedullary Femoral Nail System

## C. Indications for use of the Device

510(k) Number (if known):

Device Name: **MAGELLAN™ Intramedullary Femoral Nail System**

### Indications for Use:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109) Or Over-the-Counter Use ☐ (Optional Format 1-2-96)

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