(70 days)
MAGELLAN™ Femoral Nail manufactured by Wright Medical Technology, Inc., Russell-Taylor Femoral Nail System manufactured by Smith and Nephew
Not Found
No
The description focuses on the mechanical components and a magnetic targeting system, with no mention of AI or ML.
Yes
The device is indicated for use in stabilizing bone fractures and conditions like nonunions and malunions, which are medical conditions, and thus it provides therapy.
No
The device is an intramedullary nail system used for stabilizing long bone shaft fractures of the femur. Its function is to fix and support the bone, not to diagnose a condition.
No
The device description clearly outlines a system composed of physical components like nails, screws, and instrumentation made of stainless steel, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The MAGELLAN™ Intramedullary Femoral Nail System is a surgical implant used to stabilize bone fractures in the femur. It is a physical device inserted into the body during surgery.
- Lack of Specimen Analysis: The description and intended use clearly indicate that this device is used directly on the bone within the body and does not involve the analysis of any biological specimens.
Therefore, based on the provided information, the MAGELLAN™ Intramedullary Femoral Nail System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
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 crosslocked 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur (long bone shaft)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MAGELLAN™ Femoral Nail manufactured by Wright Medical Technology, Inc., Russell-Taylor Femoral Nail System manufactured by Smith and Nephew
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a stylized letter "W" formed by two triangles. The triangles are positioned side by side, with the left triangle slightly overlapping the right one. A thin, diagonal line runs from the top left to the bottom right, creating the impression of a continuous "W" shape. A small registered trademark symbol is located at the bottom right of the image.
Image /page/0/Picture/1 description: The image shows the text "WRIGHT MEDICAL TECHNOLOGY, INC." in a bold, serif font. The words "WRIGHT" are in a larger font size than the rest of the text. Below the text is the address "5677 AIRLINE ROAD" and "ARLINGTON, TN 38002". The text is black and the background is white.
Contact Person: Date:
Cristie Manuel March 26, 1997
510(k) Summary
Trade/Proprietary Name: Common Name: Classification: Predicate Device:
MAGELLAN™ Intramedullary Nail System Intramedullary Fixation Rod and Accessories Class II MAGELLAN™ Femoral Nail manufactured by Wright Medical Technology, Inc. and the Russell-Taylor Femoral
JUN - 5 1997
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 crosslocked 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The overall design is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
JUN - 5 1997
Ms. Cristie Manuel Requlatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re : K971135 MAGELLAN™ Intramedullary Femral 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 The general controls provisions of the Act of the Act. include requirements for annual registration, 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq 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.
2
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 (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 ene orige or compliand, "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,
to celia
. Celia M. Witten, Ph.D., M.
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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C. Indications for use of the Device
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MAGELLAN™ Intramedullary Femoral Nail System
Indications for Use:
14
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.
(Please do not write below this line-continue on another page if needed)
彩 米 水 Concurrence of CDRH, Office of Device Evaluation (ODE)
b colla
Prescription Use
(Per 21 CFR 801.109)
Or
Over-the-Counter Use_
(Optional Format 1-2-96)
000009