The sponsor utilized a retrospective registry study and clinical literature to compare clinical and radiographic outcomes between patients treated before age 10 (predicate population) and patients treated at age 10 or older (subject population) to support substantial equivalence.
The MAGEC Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to early-onset scoliosis 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.
Device Story
MAGEC Spinal Bracing and Distraction System is a non-fusion growing rod system for early-onset scoliosis. System consists of sterile, single-use titanium (Ti-6Al-4V) rods implanted via surgical fixation (pedicle screws, hooks, connectors). Rods contain an internal magnet; an electrically powered, hand-held External Remote Controller (ERC) is placed over the patient's spine to non-invasively rotate the magnet, causing rod distraction or retraction. Periodic distraction lengthens the spine to minimize scoliosis progression during growth. Used in clinical settings by physicians. Output is mechanical spinal distraction; clinical decision-making relies on radiographic monitoring of Cobb angle and thoracic height. Benefits include non-invasive lengthening, reducing need for repeated surgeries.
Clinical Evidence
Retrospective registry study of 1,252 pediatric patients with early-onset scoliosis. Group 1 (predicate population, <10 years, N=1,080) compared to Group 2 (subject population, ≥10 years, N=172). Primary endpoints: Major curve Cobb angle change, thoracic height (T1-T12) change, and spinal height (T1-S1) change. Results: Group 2 showed 25.0% Cobb angle reduction, 15.5% thoracic height increase, and 15.3% spinal height increase, comparable to Group 1 (26.5%, 15.1%, 15.3% respectively). Device-related adverse events were 8.1% in Group 2 vs 35.3% in Group 1.
Technological Characteristics
Materials: Ti-6Al-4V (ASTM F136). Principle: Magnetic actuation for spinal distraction. Energy: Electrically powered external remote controller (ERC). Form factor: Implantable rods with internal magnet. Connectivity: None. Sterilization: Sterile single-use rods.
Indications for Use
Indicated for skeletally immature patients of any age with severe progressive spinal deformities (Cobb angle ≥30°; thoracic height <22 cm) secondary to early-onset scoliosis associated with or at risk of Thoracic Insufficiency Syndrome (TIS).
Regulatory Classification
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.
Special Controls
*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.
MAGEC Spinal Bracing and Distraction System (K161751)
Magec Spinal Bracing And Distraction System (K140613)
Submission Summary (Full Text)
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February 6, 2024
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Nu Vasive Specialized Orthopedics, Incorporated Miriam Cervantes Senior Regulatory Affairs Specialist 101 Enterprise Suite 100 Aliso Viejo, California 92656
Re: K233593
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 Dated: November 8, 2023 Received: November 8, 2023
Dear Miriam Cervantes:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin
O'neill -S
Colin O'Neill, M.B.E. Assistant 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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# Indications for Use
510(k) Number (if known) K233593
Device Name
MAGEC Spinal Bracing and Distraction System
### Indications for Use (Describe)
The MAGEC Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to earlyonset scoliosis 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) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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K233593 Page 1 of 5
## MAGEC Spinal Bracing and Distraction System 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
#### A. Submitted bv:
Miriam Cervantes Senior Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (909) 229-7836
Date Prepared: November 7, 2023
#### B. Device Name
Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Regulation Number: Product Code:
MAGEC Spinal Bracing and Distraction System Non Fusion Growing Rod System Growing Rod System- Magnetic Actuation Class II 21 CFR § 888.3070 PGN
#### C. Predicate Devices
The subject MAGEC Spinal Bracing and Distraction System is substantially equivalent to the primary predicate MAGEC® System (K201543) and additional predicates MAGEC® Spinal Bracing and Distraction System (K161751) and Magec Spinal Bracing And Distraction System (K140613).
#### D. Device Description
The subject MAGEC Spinal Bracing and Distraction System has an identical design and principle of operation to the predicate design iterations cleared in the predicate Magec System (K201543, K161751, K140613). The subject system includes sterile single use MAGEC rods manufactured from Ti-6Al-4V, conforming to ASTM F136, along with various accessories including a sterile Rod Template and Manual Distractor, a non-sterile Wand Magnet Locator, and is compatible with a hand held External Remote Controller (ERC) 1 or 2. The MAGEC rod can be surgically implanted using appropriate NuVasive Reline 4.5-5.0 (Reline Small Stature or RSS) or Armada fixation components (i.e., pedicle screws, hooks and/or connectors). 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 implanted magnet to rotate and either distract or retract the rod. Periodic distraction of the rod is performed to lengthen the spine and to provide adequate bracing during growth to
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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.
The purpose of this premarket notification is to expand the indications for use to include treatment of skeletally immature patients of any age with early onset scoliosis.
#### E. Indications for Use
The MAGEC Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to early-onset scoliosis 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.
#### Technological Characteristics F.
As was established in this submission, the subject MAGEC System is substantially equivalent to its predicate devices cleared by the FDA for commercial distribution in the United States. The subject device has been shown to be substantially equivalent and have equivalent technological characteristics to the predicate through comparison in areas including clinical use, design, material composition, intended use, and function.
The following table describes the summary comparison of technological characteristics of the subject device with the predicate device:
| | Subject Device | Predicate Device<br>(K201543/K161571/K140613) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The MAGEC Spinal Bracing and<br>Distraction System is indicated for<br>skeletally immature patients with<br>severe progressive spinal deformities<br>(e.g., Cobb angle of 30 degrees or<br>more; thoracic spine height less than<br>22 cm) secondary to early-onset<br>scoliosis associated with or at risk of<br>Thoracic Insufficiency Syndrome<br>(TIS). TIS is defined as the inability<br>of the thorax to support normal<br>respiration or lung growth. | The Magec System is indicated for<br>skeletally immature patients less than<br>10 years of age with severe<br>progressive spinal deformities (e.g.,<br>Cobb angle of 30 degrees or more;<br>thoracic spine height less than 22 cm)<br>associated with or at risk of Thoracic<br>Insufficiency Syndrome (TIS). TIS is<br>defined as the inability of the thorax to<br>support normal respiration or lung<br>growth. |
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| Explanation of<br>differences in<br>Indications for<br>Use | The subject device is indicated for<br>skeletally immature patients of any<br>age with early-onset scoliosis. The<br>purpose of specifying early-onset<br>scoliosis is to explicitly identify the<br>treated condition for patients,<br>surgeons, hospitals, and payers. It is<br>solely to clarify the indications. This<br>does not change the intended patient<br>population or treated conditions. | The predicate device is indicated for<br>use in skeletally immature patients<br>less than 10 years of age. |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>the technology<br>similarities to<br>the predicate<br>device | • Principle of Operation: Brace the<br>spine during growth to minimize<br>the progression of scoliosis<br>• Material Composition: Titanium<br>• Design: Magnetic mechanism<br>• Accessories: Magec Manual<br>Distractor, Magec Rod Template,<br>and Magec Wand Magnet Locator | • Principle of Operation: Brace the<br>spine during growth to minimize<br>the progression of scoliosis<br>• Material Composition: Titanium<br>• Design: Magnetic mechanism<br>• Accessories: Magec Manual<br>Distractor, Magec Rod Template,<br>and Magec Wand Magnet Locator |
| Summary of<br>the technology<br>differences to<br>the predicate<br>device | Identical to predicate | No change in technology |
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#### C. Performance Data
MAGEC System The subject to the predicate Magec System (K201543/K161571/K140613). There have been no design changes introduced as part of this submission. The purpose of this submission is to expand the indications for use of the MAGEC System to include treatment of skeletally immature patients of any age with early onset scoliosis.
The following non-clinical testing was previously provided and reviewed by FDA:
- Biocompatibility evaluation per ISO 10993-1, including cytotoxicity per ISO 10993-5, chemical characterization per ISO 10993-18 and toxicological risk assessment per ISO 10993-17
- Wear Debris Testing and Post-Wear Debris Testing Device Analysis
As the subject MAGEC System device is identical to the predicate Magec System (K201543/K161571/K140613) device in design, material, and manufacturing, there are no new risks related to biocompatibility of the subject device when compared to the predicate.
Additionally, a large retrospective registry study of pediatric early-onset scoliosis patients treated with the subject device was performed. The study population consisted of patient groups:
- 1. Group 1: Age at index MAGEC implantation at less than 10 years (N= 1,080 patients)
- 2. Group 2: Age at index MAGEC implantation at 10 years or greater (N= 172 patients)
All patients were diagnosed to have early-onset scoliosis before 10 years of age. All patients were treated with the MAGEC System. In total, there were 1,252 patients treated with the MAGEC System, including 1,080 patients treated before 10 years of age, and 172 patients who were treated with the MAGEC System at 10 years of age or older. The clinical and radiographic data demonstrates that the MAGEC System device, when used in patients 10 years of age or older, is substantially equivalent to the predicate Magec System device indicated for use in patients younger than 10 years of age. Any potential hazards of the changes introduced as part of this submission have been evaluated and assessed to have risk mitigators, and any relevant information has been addressed in the subject device labeling, after all control measures have been implemented.
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K233593
| Data Source | Registry Study | | Literature |
|-----------------------------------|----------------|--------------|------------------|
| Study Group | Group 1 | Group 2 | Group B |
| | (Predicate) | (Subject) | (Subject) |
| Age at Magec implantation | <10 years | ≥10 years | ≥10 years |
| Demographic Information | | | |
| N | 1,080 | 172 | 57 |
| Age, mean (range) | 6.9 (1-9) | 11.3 (10-16) | 11.4 (10.0-18.4) |
| Clinical Outcomes | | | |
| Major curve Cobb angle, Δ, mean | 26.5% | 25.0% | 36.6% |
| Thoracic height (T1-T12), Δ, mean | 15.1% | 15.5% | 16.4% |
| Spinal height (T1-S1), Δ mean | 15.3% | 15.3% | 15.4% |
| Device-related adverse events | 35.3% | 8.1% | 10.5% |
The results demonstrate that the subject MAGEC System is substantially equivalent to the predicate.
#### H. Conclusions
The subject MAGEC Spinal Bracing and Distraction System has been shown to be substantially equivalent to the legally marketed predicate device for its intended use.
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In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
