The Coligne GII Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GII Spinal Fixation System is intended for use in the non-cervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft, the GII Spinal Fixation System is intended for use or more of the following; (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma.

This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.

Device Description

The GII Spinal Fixation System is a top loading polyaxial pedicle screw, which, when used with rods and crosslinks, results in a multiple component, posterior system. All the components are available in a variety of sizes to match the patient's anatomy more closely.

AI/ML Overview

This document outlines the FDA's 510(k) premarket notification clearance for the Coligne GII Spinal Fixation System. The focus of the 510(k) submission is to add flexStaas pedicle screws to the existing system.

Based on the provided text, the device in question is a Spinal Fixation System, and the "study" referred to is a non-clinical test summary to demonstrate that the new component (flexStaas pedicle screws) meets performance criteria compared to predicate devices. There were no clinical studies performed.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the flexStaas pedicle screws of the GII Spinal Fixation System met or exceeded acceptance criteria for two specific non-clinical tests. However, the specific quantitative acceptance criteria values are not explicitly stated in this document. Only the types of tests and the outcome ("met or exceeded") are provided.

Acceptance Criteria (Quantitative - Not explicitly stated in the document)	Reported Device Performance
Dynamic flexion-extension per ASTM F1798: (Specific load/displacement/cycles not provided)	Met or exceeded acceptance criteria
Torsional strength of screw/screwdriver interface: (Specific torque/failure limit not provided)	Met or exceeded acceptance criteria

Note: The document only provides a qualitative summary of the non-clinical test results. The actual quantitative acceptance criteria and the measured performance values would be detailed in the full test reports, which are not included in this FDA clearance letter.

Study Information (Non-Clinical)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the non-clinical tests. The number of samples for dynamic flexion-extension and torsional strength tests is typically specified in the test protocols, but not in this summary.
- Data Provenance: The tests were performed "in support of this Special 510(k)". It is implied that these tests were conducted by the manufacturer, Coligne AG, or a contracted testing facility. The country of origin of the data is not specified beyond the company being located in Zurich, Switzerland. The tests are prospective in the sense that they were performed to support the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a non-clinical, mechanical testing study, not a study involving expert review of medical images or patient outcomes. The "ground truth" for mechanical tests is defined by established engineering standards (ASTM F1798) and material properties.
Adjudication method for the test set:
- Not Applicable. This was a non-clinical, mechanical testing study. Adjudication methods like 2+1 or 3+1 are used for human reader studies or when establishing ground truth from multiple expert opinions.
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:
- No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted. This device is a mechanical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm. Standalone performance refers to the accuracy or performance of an AI algorithm independent of human intervention.
The type of ground truth used:
- For the non-clinical tests, the "ground truth" is based on established engineering standards (specifically ASTM F1798 for dynamic testing) and material property specifications (e.g., strength requirements for medical implants). It's not a medical "ground truth" like pathology or clinical outcomes.
The sample size for the training set:
- Not Applicable. The document describes a mechanical device requiring non-clinical testing, not a machine learning model that would have a training set.
How the ground truth for the training set was established:
- Not Applicable. As no training set was involved (this is a mechanical device), no ground truth for a training set needed to be established.

Summary

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May 19, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Coligne AG % J.D. Webb President The OrthoMedix Group, Inc. 4313 W. 3800, S. West Haven, Utah 84401

Re: K210306

Trade/Device Name: GII Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: April 14, 2021 Received: April 21, 2021

Dear J.D. Webb:

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. 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 located 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.

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

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801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 (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,

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210306

Device Name GII Spinal Fixation System

Indications for Use (Describe)

This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.

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 the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Coligne AG is hereby submitting this 510(k) Summary.

1. Date Prepared

May 18, 2021

2. Submitter [510(k) owner]

Coligne AG Utoquai 43 8008 Zurich, SWITZERLAND Phone: 41-43-3438000

3. Primary Contact

J.D. Webb 4313 W. 3800 S West Haven, UT 84401 512-590-5810 Tele e-mail: jdwebb@orthomedix.net

4. Submitted Device Information

Trade Name: GII Spinal Fixation System Common Name: pedicle screw

5. Classification Information

Classification: Class II Classification Regulation: 21 CFR 888.3070; Thoracolumbosacral pedicle screw system Classification Product Code: NKB Device Panel: Orthopedic

6. Reason for Submission

The reason for the current 510(k) is to add the flexStaas pedicle screws to the GI Spinal Fixation System.

7. Legally Marketed Predicate Devices

The flexStaas pedicle screws of the GII Spinal Fixation System manufactured by Coligne AG are substantially equivalent to the following devices currently in commercial use:

Primary Predicate Device

Device: GII-Ti-Poly-Axial Screw Company: Coligne AG 510(k) number: K083567

Additional Predicate Devices

Device: GII Spinal Fixation System Company: Coligne AG 510(k) number: K032604 Device: CD Horizon Spinal System Company: Medtronic 510(k) number: K202771

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8. Submitted Device Description

9. Materials

Ti-6AI-4V ELI (ISO 5832-3)

10.Indications for Use

The Coligne GII Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GI Spinal Fixation System is intended for use in the noncervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft, the GII Spinal Fixation System is intended for use or more of the following: (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma.

This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.

11.Substantial Equivalence

The flexStaas pedicle screws of the GII Spinal Fixation System are substantially equivalent to the predicate devices in terms of intended use, design, manufacturing materials, principles of operation, and technical characteristics, and raises no new issues of safety or effectiveness.

12. Summary of the Technological Characteristics Compared to Predicate

Intended Use

The flexStaas pedicle screws of the GII Spinal Fixation System and the predicates are intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Materials

The flexStaas pedicle screws of the GI Spinal Fixation System use the same material as the predicates.

Design

The flexStaas pedicle screws of the GII Spinal Fixation System and the predicates are equivalent in terms of shape and function.

Dimensions

The flexStaas pedicle screws of the GI Spinal Fixation System and the predicates are equivalent in their dimensions.

Strength

The flexStaas pedicle screws of the GII Spinal Fixation System have greater or equivalent strength values compared to the predicates.

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13.Non-clinical Test Summary

The following tests were performed in support of this Special 510(k):

1. Dynamic flexion-extension per ASTM F1798
Torsional strength of screw/screwdriver interface 2.

The testing showed that the flexStaas pedicle screws of the GII Spinal Fixation System met or exceeded acceptance criteria.

14. Clinical Test Summary

No clinical studies were performed.

15. Conclusions: Non-clinical and Clinical

Coligne AG considers the flexStaas pedicle screws of the GII Spinal Fixation System to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.

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.