MAGEC® Spinal Bracing and Distraction System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below. July 29, 2022 Nuvasive Specialized Orthopedics, Inc. Rebecca Shelburne Walker Regulatory Affairs Manager 101 Enterprise, Suite 100 Aliso Viejo, California 92656 Re: K161751 Trade/Device Name: MAGEC® Spinal Bracing and Distraction System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGN Dear Rebecca Walker: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 2, 2016. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 21 CFR 888.3070. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ronald Jean, OHT6: Office of Orthopedic Devices, (301)796-5650, Ronald.Jean@fda.hhs.gov Sincerely, Ronald P. Jean -S Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the department's focus on people and health. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 2, 2016 NuVasive Specialized Orthopedics, Inc. Ms. Rebecca Shelburne Walker Regulatory Affairs Manager 101 Enterprise, Suite 100 Aliso Viejo, California 92656 Re: K161751 Trade/Device Name: MAGEC® Spinal Bracing and Distraction System Regulatory Class: Unclassified Product Code: PGN Dated: June 23, 2016 Received: June 24, 2016 Dear Ms. Walker: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {2}------------------------------------------------ forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161751 Device Name MAGEC® Spinal Bracing and Distraction System Indications for Use (Describe) The MAGEC® Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal abnormalities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. Type of Use (Select one or both, as applicable) | <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Underneath that is the text "a division of NuVasive, Inc." in a smaller font. ## 510(k) Summary ### MAGEC® Spinal Bracing and Distraction System | 1. | Company: | NuVasive Specialized Orthopedics, Inc.<br>101 Enterprise, Suite 100<br>Aliso Viejo, CA 92656 | |----|----------|----------------------------------------------------------------------------------------------| |----|----------|----------------------------------------------------------------------------------------------| Contact: Rebecca Shelburne Walker Regulatory Affairs Manager Phone: (949) 837-3600 x227 Fax: (949) 837-3664 Date Prepared: August 23, 2016 - 2. Proprietary Trade Name: MAGEC® Spinal Bracing and Distraction System 3. Common Name: Non Fusion Growing Rod System - Classification Name: Unclassified (Product Code PGN, Growing Rod System - Magnetic 4. Actuation) న్. Product Description: The MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® and Armada® fixation components, or Stryker® Xia® fixation components (i.e. pedicle screws, hooks and/or connectors). The implanted MAGEC rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a non-sterile hand held External Remote Controller (ERC or ERC 2) that is used periodically after implantation to non-invasively distract the implanted spinal rod. The titanium MAGEC rod includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the magnet within the implanted MAGEC rod to rotate and distract. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC System is made of Radel® and contains a rare-earth magnet. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC rod. The ERC is placed over this location on the child's back. Indications for Use: The MAGEC Spinal Bracing and Distraction System is intended for 6. skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for NuVasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic to the left of the company name, "NUVASIVE," in silver lettering. Below the company name is the text "SPECIALIZED ORTHOPEDICS, INC." in purple, followed by the text "a division of NuVasive, Inc." in a smaller font size. Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. 7. Substantial equivalence: Documentation that includes mechanical test results and detailed comparison to the predicate device demonstrates that the MAGEC System is substantially equivalent to the following 510(k) cleared device: - MAGEC Spinal Bracing and Distraction System (K150885) The purpose of this premarket notification is to revise the labeling to include the NuVasive 5.5 mm Reline and Armada Pedicle Screw Systems. Substantial equivalence to the predicate device is based on indications for use, principles of operation and technological characteristics. The MAGEC System that is the subject of this premarket notification is identical to the predicate device and has the same indications for use. All design and technological characteristics remain the same. Non-clinical testing on the MAGEC System was performed to evaluate compatibility with the worst-case pedicle screw system. Pyrogen testing was performed on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices. The FDA guidance document "Guidance for Industry and FDA Staff: Spinal System 510(k)s" was utilized to determine the specific non-clinical tests required to establish compatibility. | Test Description | Applicable Test Standard | |------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Static Compression Bending | ASTM F1717-14: Standard Test Methods for Spinal<br>Implant Constructs in a Vertebrectomy Model | | Static Torsion | | | Dynamic Compression Bending | | | Pyrogenicity - LAL (Kinetic Turbidimetric Assay<br>Pyrogen Test) | ANSI/AAMI ST72:2011 – Bacterial Endotoxins – Test<br>Methods, Routine Monitoring, and Alternatives to Batch<br>Testing | There are no changes being made to the MAGEC Rod or the accessories as a result of this submission. therefore all testing that was performed on the predicate MAGEC System for those components are applicable to this premarket notification. #### 8. Clinical Performance Data: The safety and probable benefit of the predicate MAGEC System was evaluated outside the United States in a retrospective clinical study for children who had either a primary or revision spinal bracing procedure using the MAGEC System. In assessing probable benefit, the endpoints chosen in the study included Cobb angle correction in the coronal plane, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in the number of subsequent surgical procedures, and weight gain. The results of the clinical study showed the MAGEC System provides the benefits of spinal deformity correction and continued growth, similar to that for traditional growing rods, without the need for regular {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for NuVasive Specialized Orthopedics, Inc. The logo features a stylized leaf-like shape in purple and gray on the left. To the right of the shape is the company name, "NUVASIVE," in silver, followed by "SPECIALIZED ORTHOPEDICS™, INC." in purple. Below that is the text "a division of NuVasive, Inc." surgical lengthening procedures in these children. As with traditional growing rods, the MAGEC System provides direct bracing to the spine. This bracing provides for correction and maintenance of the scoliotic curve as defined by the Cobb Angle. In addition, a return to a more normal symmetry of the thoracic cavity is provided as demonstrated by the space available for lung (SAL). While implantation of the MAGEC System shares many of the same risks and hazards associated with those of traditional growing rods, the MAGEC System offers the benefit of non-invasive adjustment to lengthen the implanted rod without the need to perform another surgery. The ability of the device to be adjusted non-invasively in length provides the ability of the spine to continue growing in these subjects and for the Thoracic Spine Height to increase with this growth. #### 9. Conclusion: Conclusions can be drawn from these tests that the MAGEC System with the modified labeling is substantially equivalent to the predicate device.