The MediRod Pedicle Screw System, with or without MIS instrumentation, is 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 thoracic, lumbar. and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the MediRod Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the MediRod Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The MediRod Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws and rods manufactured from titanium alloy. All the components are available in a variety of sizes to match more closely the patient's anatomy.

AI/ML Overview

This document is a 510(k) summary for the "MediRod Pedicle Screw System." It does not describe a study involving device performance metrics, accuracy, or human reader involvement in the context of AI or diagnostic systems. Instead, this document focuses on the mechanical performance testing of a physical medical device (pedicle screws) to demonstrate substantial equivalence to predicate devices for FDA clearance.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment, as typically applied to AI/diagnostic devices, is not available or applicable in this document.

The document states:

Performance Testing: "Static and dynamic testing of the MediRod Pedicle Screw System was performed in accordance with ASTM F1717 (static and dynamic compression bending, and static torsion testing) and ASTM F1798 (static flexion-extension testing)."
Conclusion: "Results of the testing demonstrate the substantially equivalent mechanical performance of the subject device."

This indicates that the acceptance criteria are based on meeting the standards set forth in ASTM F1717 and ASTM F1798 for mechanical properties, and the study "proves" the device meets these criteria by demonstrating substantial equivalence in mechanical performance to legally marketed predicate devices. However, no specific numerical acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity) are provided in the text.

Summary

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November 13, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CMF Medicon Surgical Inc. % Matthias Alber Executive Vice President CMF Medicon Surgical Inc 11200 St. Johns Industrial Pkwy N. Suite 1 Jacksonville, Florida 32246

Re: K242764

Trade/Device Name: MediRod Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: August 29, 2024 Received: September 13, 2024

Dear Matthias Alber:

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 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 Rue"). 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 medical devices and radiation-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).

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Image /page/2/Figure/2 description: The image shows a digital signature. The signature is for Ryan Trombetta -S and the date is 2024.11.13 19:04:02 -05'00'. The signature is for 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

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Indications for Use

Submission Number (if known)

K242764

Device Name

MediRod Pedicle Screw System

Indications for Use (Describe)

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)

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510(k) Summary

In accordance with Title 21 of the Code of the Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitter's Name and Address:	CMF MEDICON SURGICAL INC11200 St. Johns Industrial Pkwy N. Suite 1Jacksonville, FL 32246USA
Official Contact:	Matthias AlberExecutive Vice President
Contact Person and Telephone:	Matthias Alber904-642-7500
Date Summary Prepared:	09/06/2024
Device Name:	Common Name - Thoracolumbosacral Pedicle ScrewSystemProprietary Name – MediRod Pedicle ScrewSystem
Device Class:	Class II
Classification:	21 CFR section 888.3070
Product Code:	NKB
Predicate Devices
Primary Predicate Device:	Astura Medical - OLYMPIC Posterior Spinal FixationSystem
Additional Predicate Device:	Spineart - PERLA® TL Posterior Thoraco-lumbar FixationSystem (K181139)System (K193396)

Device Description:

Indication for Use:

The MediRod Pedicle Screw System, with or without MIS instrumentation, is 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 of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

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When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the MediRod Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the MediRod Pedicle Screw System is intended to treat pediatric patients diagnosed with spondvlolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Technoloqical Characteristics:

As was established in this submission, the subject MediRod Pedicle Screw System is substantially equivalent to the other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent to predicate devices based on technological characteristics, intended use, performance, material composition, and function.

Performance Testing:

Static and dynamic testing of the MediRod Pedicle Screw System was performed in accordance with ASTM F1717 (static and dynamic compression bending, and static torsion testing) and ASTM F1798 (static flexion-extension testing). Results of the testing demonstrate the substantially equivalent mechanical performance of the subject device.

Conclusion:

Based on the indication for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject MediRod Pedicle Screw System has been shown to be substantially equivalent to the legally marketed predicate devices.

Regulation Number and Section

N/A