(34 days)
Harrington Rod System, Preamendment
No
The device description and performance studies focus on mechanical and functional aspects of the rod and external controller, with no mention of AI or ML algorithms for image analysis, decision support, or control.
Yes.
The device is intended to treat severe progressive spinal deformities, which are medical conditions. The explicit mention of improving outcomes (Cobb angle correction, thoracic spine height increase, etc.) indicates a therapeutic function.
No
The device is a spinal bracing and distraction system designed to minimize the progression of scoliosis and allow for spinal growth. Its primary function is therapeutic (bracing and lengthening the spine), not diagnostic (identifying or characterizing disease).
No
The device description clearly outlines multiple hardware components including a surgically implanted spinal rod, an external remote controller (ERC), a manual distractor, and a wand magnet locator. While the ERC is electrically powered and likely contains software for control, the system is fundamentally a hardware-based medical device with software as a component for operation.
Based on the provided text, the Ellipse MAGEC Spinal Bracing and Distraction System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The MAGEC system is a surgically implanted device (spinal rod) and an external controller used to mechanically brace and lengthen the spine. It directly interacts with the patient's body to treat a physical condition (spinal deformity).
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens from the patient. The device's function is based on mechanical manipulation and bracing of the spine.
Therefore, the MAGEC Spinal Bracing and Distraction System falls under the category of a surgical implant and a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ellipse MAGEC Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (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.
Product codes (comma separated list FDA assigned to the subject device)
PGN
Device Description
The Ellipse Technologies, Inc. MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The titanium rod (Ti-6Al-4V ASTM F136) 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. Rotation of the magnet causes the MAGEC rod to be lengthened or shorten.
The hand held non-invasive ERC is electrically powered. The ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either lengthen or shorten the rod. Periodic lengthening of the rod is performed to distract the spine and to provide adequate bracing during growth to minimize the progression of scoliosis. 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 sterilizable, single use device, which is used in the operating room to test the device prior to implantation. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy, X-ray, CT
Anatomical Site
Spine / Thorax
Indicated Patient Age Range
skeletally immature patients less than 10 years of age
Intended User / Care Setting
Physician, operating room
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)
Non-Clinical Performance Data:
- Study Type: Static Mechanical Testing, Dynamic Mechanical Testing, Shelf Life Packaging Validation, Sterilization of healthcare products (Radiation - Part 2: Establishing the sterilization dose), Biocompatibility, Device functionality and verification, Electrical Safety, Electrical Interference and Compatibility (EMC/EMI), Magnetic Field Safety, Software.
- Key Results: Results of these tests demonstrate the MAGEC Spinal Bracing and Distraction System can be expected to perform in a manner substantially equivalent to the predicate devices. Design functionality and verification, shelf life testing, validation of the gamma radiation cycle in accordance with the VDmar 20 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6, and biocompatibility in accordance with ISO 10993-1 for the intended use of the device was performed.
In vivo animal studies:
- Study Type: In vivo animal studies (porcine model)
- Sample Size: Nine male Yucatan pigs
- Key Results: Results of the in vivo porcine study demonstrates that the MAGEC System is safe and provides an efficient means of non-invasive distraction of the spine. No complications from distraction occurred.
Clinical Performance Data:
- Study Type: Retrospective clinical study
- Data Source: Outside the United States
- Key Results: 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 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 to 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.
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.
Harrington Rod System, Preamendment
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.
K101997, K113695, K113219, K131677, K133289
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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July 29, 2022
Ellipse Technologies, Incorporated John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway Suite 123 Irvine, California 92618
Re: K140178
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 John McIntyre:
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 February 27, 2014. 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
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Food and Drug Administration 903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
· February 27, 2014
Ellipse Technologies, Incorporated John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway Suite 123 Irvine, California 92618 US
Re: K140178
Trade/Device Name: MAGEC® Spinal Bracing and Distraction System Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: PGN Dated: January 23, 2014 Received: January 24, 2014
Dear Mr. McIntyre:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Mr. John McIntyre
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers. International and Consumer Assistance 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.
Sincerely yours,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140178
Device Name
MAGEC® Spinal Bracing and Distraction System
Indications for Use (Describe)
The Ellipse MAGEC Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
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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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com
510(k) Summary
MAGEC® Spinal Bracing and Distraction System
Premarket Notification Number: K140178
Ellipse Technologies, Incorporated 1. Company: 13900 Alton Parkway, Suite 123 Irvine, CA 92618
Contact:
Date Prepared:
John McIntyre Vice President. RA/QA/CA Phone: (949) 837-3600 x203 Fax: (949) 837-3664 February 25. 2014
- Proprietary Trade Name: MAGEC® Spinal Bracing and Distraction System
Non Fusion Growing Rod System 3. Common Name:
Classification Name: Unclassified (Product Code PGN, Growing Rod System -4. Magnetic Actuation)
Harrington Rod System, Preamendment 5. Predicate Device:
Product Description: The Ellipse Technologies, Inc. MAGEC Spinal Bracing and 6. Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen the implanted spinal The implanted spinal rod is used to brace the spine during growth to minimize the rod. progression of scoliosis. The titanium rod (Ti-6Al-4V ASTM F136) includes an actuator portion
6
13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com
that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC. Rotation of the magnet causes the MAGEC rod to be lengthened or shorten.
The hand held non-invasive ERC is electrically powered. The ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either lengthen or shorten the rod. Periodic lengthening of the rod is performed to distract the spine and to provide adequate bracing during growth to minimize the progression of scoliosis. 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 sterilizable, single use device, which is used in the operating room to test the device prior to implantation. 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.
Intended Use: The Ellipse MAGEC Spinal Bracing and Distraction System is 7. intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (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.
- Substantial equivalence: Substantial equivalence to the preamendment Harrington Rod System is based on similar indications for use, technological characteristics, and on pre-clinical testing and clinical data.
Technological Characteristics: 9.
Both the MAGEC System and the predicate are spinal rods that have adjustable length, and are implanted on the posterior spine using hooks or screws. Both systems are manufactured of biocompatible metals and supplied sterile. The difference in the technological characteristics of the predicate device and the MAGEC System is the non-invasive distraction technology, which was previously cleared in Ellipse Orthopedic devices, K101997, K113695, K113219, K131677
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K140178 - Page 3 of 5 13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com
and K133289. This technological difference does not raise new types of issues of safety and effectiveness.
10. Non-Clinical Performance Data:
Non-clinical testing on the MAGEC System included Static and Dynamic Mechanical testing according to the methods outlined in the standard ASTM F1717 and ASTM F2627. Results of these tests demonstrate the MAGEC Spinal Bracing and Distraction System can be expected to perform in a manner substantially equivalent to the predicate devices.
In addition to mechanical testing, design functionality and verification, shelf life testing, validation of the gamma radiation sterilization cycle in accordance with the VDmar 20 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 106, and biocompatibility in accordance with ISO 10993-1 for the intended use of the device was performed.
The specific non-clinical tests that have been performed in order to establish equivalence to the predicate devices:
| Test Description | Applicable Test Standard |
|---|---|
| Static Mechanical Testing | ASTM F1717 |
| Dynamic Mechanical Testing | ASTM F2624 |
| Shelf Life Packaging Validation | ISO 11607-1 |
| Sterilization of healthcare products -- Radiation - Part 2: | |
| Establishing the sterilization dose | ANSI/AAMI/ISO 11137-2 |
| Biocompatibility | ISO 10993-1 |
| Device functionality and verification | None |
| Electrical Safety | IEC 60601-1 |
| Electrical Interference and Compatibility (EMC/EMI) | EN 60601-1-2 |
| Magnetic Field Safety | ICNIRP 2009 |
| Software | FDA "Guidance for the Content of Premarket |
| Submissions for Software Contained in Medical | |
| Devices" Issued May 11, 2005 |
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K140178 - Page 4 of 5
13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 Fax: 949-837-3664 www.ellipse-tech.com
In vivo animal studies were performed in the porcine model to evaluate the performance of the MAGEC System and verify that the MAGEC rod is safe and is able to perform per functional specifications. Nine male Yucatan pigs of similar age (mean of 7.2 mo.) were randomly assigned an identifying number and were assigned to one of two test groups designated Group 1 (MAGEC rod) and Group 2 (sham). All animals were of similar weight. Both groups were checked once each weeks for ten weeks to follow growth progress utilizing Fluoroscopy. For seven weeks post implantation, under sedation, attempted and actual distraction of the Ellipse implantable device (actuator) was recorded in Group I using the fluoroscopy images. X-ray and CT were performed post instrumentation implantation (before initial distraction), pre-implant removal, and prior to sacrifice. Results of the in vivo porcine study demonstrates that the MAGEC System is safe and provides an efficient means of non-invasive distraction of the spine. No complications from distraction occurred.
Clinical Performance Data: 11.
The safety and probable benefit of the 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 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 to those of traditional growing rods, the MAGEC System offers the
9
K140178 - Page 5 of 5
13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com
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.
Conclusion: 12.
SE
Conclusions can be drawn from these non-clinical and clinical tests that the MAGEC System is substantially equivalent to the predicate device.