The VerteGlide Spinal Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome for the following subset of patients:

· Patients who may require serial magnetic resonance imaging;
· Patients with small stature:

· Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events;

· Patients at risk for implant prominence following surgery;
· Patients with hyperkykyphotic spinal deformities; OR.

· Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery.

The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity.

The VerteGlide Navigation Compatible Instruments are intended to be used during the preparation and placement of the VerteGlide Spinal Growth Guidance System screws. The VerteGlide Navigation Compatible Instruments have the option to be used with or without Medtronic StealthStation® System. Use of VerteGlide Navigation Compatible Instruments with Medtronic StealthStation® System during spinal surgery can assist the surgeon in precisely locating anatomical structures in the VerteGlide Spinal Growth Guidance System procedures. The Medtronic StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The VerteGlide Spinal Growth Guidance System consists of longitudinal members (rods), anchors (screws), and interconnection components (cross connector and rod clamp) in a variety of sizes to accommodate differing anatomic requirements. The VerteGlide Spinal Growth Guidance System also include surgical instruments.

The VerteGlide Spinal Growth Guidance System offers a solution for early-onset scoliosis (EOS) patients with potential for additional spinal growth. Fusion screws are used at the apex of the curve to rigidly lock the rod in place, while sliding (non-fusion) screws are used above and below the apex to stabilize but allow for continued growth. A unique rod design is used to provide rigid fixation of the fusion screws and further promote sliding of the non-fusion screws. Fixation to the bone is provided using standard fusion and non-fusion pedicle screws. While the non-fusion pedicle screws are rigidly fixed to the bone, they also allow for sliding along the rod axis during normal growth without requiring separate rod lengthening procedures. The VerteGlide Spinal Growth Guidance System allows for deformity correction and minimizes repeat surgeries needed until skeletal maturity.

The components of the VerteGlide Spinal Growth Guidance System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

AI/ML Overview

The provided text describes the VerteGlide Spinal Growth Guidance System, a medical device. However, it does not detail a study that proves the device meets specific acceptance criteria in the manner requested (i.e., a clinical study with performance metrics like sensitivity, specificity, or accuracy in a diagnostic context).

The document is an FDA 510(k) clearance letter and a 510(k) Summary for a spinal growth guidance system. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a diagnostic or AI-driven system.

The "Performance Data" section primarily addresses biocompatibility, MR compatibility, and mechanical performance of the physical implant components. It states these aspects meet relevant ASTM and ISO standards, which serve as acceptance criteria for the hardware itself.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria (from standards)	Reported Device Performance
Biocompatibility	Conformance with ISO 10993-1	Performed in conformance with ISO 10993-1
MR Compatibility	ASTM F2052 (RF Heating), ASTM F2213 (Displacement Force and Torque), ASTM F2182 (Image Artifact), ASTM F2119 (Image Artifact)	Determined to be MR Conditional and will be labeled as such.
Mechanical Performance	Static and Dynamic compression (ASTM F1717)Dynamic four-point bending (ASTM F2193)Axial, torsional grip, static and dynamic flexion extension (ASTM F1798)Screw pull-out strength (ASTM F543)Tulip-shank dissociation testingConstruct wear test	Demonstrated substantially equivalent mechanical performance as compared to the predicate.

2. Sample size used for the test set and the data provenance: Not applicable. This was a physical device testing, not an algorithmic performance evaluation on a patient dataset. The "test set" would refer to the physical samples tested for mechanical strength, biocompatibility, etc., the details of which are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be derived from physical measurements and standard testing protocols, not expert clinical interpretation of data.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical spinal implant, not an AI or diagnostic imaging tool. The VerteGlide Navigation Compatible Instruments can be used with a Medtronic StealthStation® System, which is a navigation system, but the submission does not describe an MRMC study comparing human performance with and without this navigation assistance, nor is it the primary focus of the VerteGlide system's clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:
* Biocompatibility: Conformance to ISO 10993-1 standards (chemical/biological assays).
* MR Compatibility: Physical measurements according to ASTM standards for heating, displacement, torque, and artifact generation.
* Mechanical Performance: Physical measurements (e.g., force, displacement, wear) against specified limits and comparison to predicate device performance.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study type:
The study described is a benchtop (in vitro) and material-based performance evaluation to demonstrate that the physical components of the VerteGlide Spinal Growth Guidance System are safe and perform as intended, and are substantially equivalent to a predicate device. This includes:

Biocompatibility testing: To ensure the materials are not harmful to the body.
MR Compatibility testing: To determine if the device is safe for use in an MRI environment.
Mechanical performance testing: To ensure the device components have adequate strength, durability, and functional characteristics (like sliding mechanism) under simulated physiological loads and conditions.

The conclusion states that the data supports the differences between the subject and predicate devices and that the VerteGlide Spinal Growth Guidance System is substantially equivalent. A Post Market Surveillance Study (522 Order) will be issued to address potential safety concerns related to wear debris, indicating that some long-term clinical data will be collected after market entry.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. Food & Drug Administration" in blue text.

March 14, 2025

OrthoPediatrics Corp. Yan Li Regulatory Affairs Director 2850 Frontier Dr. Warsaw, Indiana 46582

Re: K241816

Trade/Device Name: VerteGlide Spinal Growth Guidance System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: PGM, OLO Dated: February 14, 2025 Received: February 14, 2025

Dear Yan Li:

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.

{1}------------------------------------------------

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).

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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

{2}------------------------------------------------

assistance/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 FDA

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

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K241816

Device Name

VerteGlide Spinal Growth Guidance System

Indications for Use (Describe)

· Patients who may require serial magnetic resonance imaging;
· Patients with small stature:

· Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events;

· Patients at risk for implant prominence following surgery;
· Patients with hyperkyphotic spinal deformities; OR.

· Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery.

The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{4}------------------------------------------------

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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

Image /page/5/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a child with a smiling face and a green body. The text "OrthoPediatrics" is written in a playful font, with the "O" in "Ortho" being a blue circle and the rest of the letters being red. There is a registered trademark symbol next to the word "Pediatrics".

510(k) Summary

I. Submitter

Submission:	Traditional 510(k) Premarket Notification
Applicant:	OrthoPediatrics Corp.
Applicant Address:	2850 Frontier Drive, Warsaw, IN 46582
Establishment Registration Number:	3006460162
Contact:	Yan Li
Contact Phone:	(574) 267-0864
Date Prepared:	March 12, 2025

II. Device

Device Trade Name:	VerteGlide Spinal Growth Guidance System
Device Classification:	II
Classification Panel:	Orthopedic
Regulation Number:	21 CFR 888.3070
Regulation Name:	Thoracolumbosacral Pedicle Screw System
Classification Product Code:	PGM, OLO
Device Classification Name	Growing Rod System

III. Predicate Device and Reference Device

Substantial equivalence is claimed to the following predicate device:

Primary Predicate Device:

SHILLA™ Growth Guidance System (K140750, Medtronic Sofamor Danek USA, Inc) -
This submission also includes the following reference device:

Reference Device:

-Response Spine System (K181390, OrthoPediatrics Corp.)

IV. Device Description

The VerteGlide Spinal Growth Guidance System consists of longitudinal members (rods), anchors (screws), and interconnection components (cross connector and rod clamp) in a variety

{6}------------------------------------------------

Image /page/6/Picture/2 description: The image is a logo for OrthoPediatrics. The logo features a cartoon drawing of a child with a smiling face and stick figure arms and legs. The word "Ortho" is written in blue and is connected to the cartoon drawing. The word "Pediatrics" is written in red.

of sizes to accommodate differing anatomic requirements. The VerteGlide Spinal Growth Guidance System also include surgical instruments.

The components of the VerteGlide Spinal Growth Guidance System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

V. Indications for Use

The VerteGlide Spinal Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, lifethreatening early onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome for the following subset of patients:

Patients who may require serial magnetic resonance imaging;
Patients with small stature; ●
Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events;
Patients at risk for implant prominence following surgery;
Patients with hyperkyphotic spinal deformities; OR
Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with ● additional spinal surgery.

The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity.

{7}------------------------------------------------

OrthoPediatrics, Corp. VerteGlide Spinal Growth Guidance System Traditional 510(k)

Image /page/7/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon figure with a smiling face and a body made of a curved line, holding the word "Ortho" in blue. The word "Pediatrics" is written in red next to "Ortho", and there is a registered trademark symbol next to the word.

medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

VI. Comparison of Technological Characteristics

The VerteGlide Spinal Growth Guidance System is substantially equivalent to the predicate device SHILLA™ Growth Guidance System (K140750) in that these devices have the same intended use and principle of operation, and many other similar fundamental technological characteristics. There are some differences between the predicate and subject devices in terms of materials, sizes and design features. The successful testing data provided in this submission supported that the differences between the subject and predicate devices do not raise new questions for safety and effectiveness.

VII. Performance Data

The Biocompatibility assessment and testing for the VerteGlide Spinal Growth Guidance System were performed in conformance with ISO 10993-1.

The implants of VerteGlide Spinal Growth Guidance System were evaluated in an MR Environment for RF Heating, Displacement Force and Torque, Image Artifact per ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, and were determined to be MR Conditional and will be labeled as such.

Mechanical performance evaluations included construct static and dynamic compression testing based on ASTM F1717; dynamic four-point bending per ASTM F2193; axial, torsional grip, static and dynamic flexion extension testing per ASTM F1798; and screw pull out strength per ASTM F543; tulip-shank dissociation testing and construct wear test. Results of the mechanical testing demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicate.

VIII. Conclusion

Information and data provided within the submission support the differences between the subject and predicate devices. Therefore, it is concluded that the VerteGlide Spinal Growth Guidance System is substantially equivalent to the predicate device. To address potential safety concerns related to the possibility of adverse wear debris, a 522 Order for a Post Market Surveillance Study will be issued for this device.

Regulation Number and Section

§ 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.