← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K971056 # MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION (K971056) _Wrightmedicaltechnologyinc · HSB · Oct 3, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K971056 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Oct 3, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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 Surgical instrument system for locating and locking distal screw holes in intramedullary femoral nails without radiographic equipment. Components include reamers for canal preparation, drill bits for proximal holes, targeting compass, magnetic target insert, targeting Steinmann pins, and drill bits for distal holes. Used with external power equipment. Operated by surgeons in clinical settings. Magnetic targeting mechanism allows alignment of distal locking screws without fluoroscopy, reducing radiation exposure to patient and surgical staff. Facilitates stabilization of femoral fractures. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Mechanical surgical instrumentation system. Includes reamers, drill bits, targeting compass, and magnetic target insert. Operates via magnetic alignment principle. No software or electronic components. ## Regulatory 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 - Preamendments Intramedullary Nail Instrumentation (Wright Medical Technology, Inc.) - Russell-Taylor Intramedullary Nail System Instrumentation (Smith and Nephew) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} OCT - 3 1997 K971056 ![img-0.jpeg](img-0.jpeg) # WRIGHT ## MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 Contact Person: Cristie Manuel Date: March 21, 1997 ## 510(k) Summary **Trade/Proprietary Name:** MAGELLAN™ Magnetic Distal Targeting System (proposed name), Product Line Extension **Common Name:** Surgical instrument motors and accessories/attachments **Classification:** Class I **Predicate Device:** Preamendments Intramedullary Nail Instrumentation (Wright Medical Technology, Inc.) Russell-Taylor Intramedullary Nail System Instrumentation (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™ 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 MAGELLAN™ 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. 000091. {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 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 Trade Name: MAGELLAN Magnetic Distal 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 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 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 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. 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 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 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, ![img-1.jpeg](img-1.jpeg) 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 {3} Premarket Notification Wright Medical Technology, Inc. MAGELLAN™ Magnetic Distal Targeting System ## C. Indications for Use of the Device 510(k) Number (if known): Device Name: **MAGELLAN™ Magnetic Distal Targeting 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. *(Please do not write below this line—continue on another page if needed)* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Concurrence of CDRH, Office of Device Evaluation (ODE) ![img-2.jpeg](img-2.jpeg) Prescription Use ☑ (Per 21 CFR 801.109) Or Over-the-Counter Use ☐ (Optional Format 1-2-96) 000009 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K971056](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K971056) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com