The Nano FortiFix® System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The Nano FortiFix® System can be used in an open approach or a percutaneous approach with MIS instrumentation.

Device Description

Nano FortiFix® is a posterior pedicle screw system consisting of rods, polyaxial and monoaxial pedicle screws, connectors and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Nano FortiFix® pedicle screw shaft is available having a nanosurface. The Nano FortiFix® nano pedicle screw has a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the nano screw threads has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These threads are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nano FortiFix® System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured?)	Reported Device Performance (Was it met?)
Mechanical Performance
* Static Compression Strength (ASTM F1717)	Demonstrated performance substantially equivalent to predicate devices.
* Dynamic Compression Strength (ASTM F1717)	Demonstrated performance substantially equivalent to predicate devices.
* Static Torsion Strength (ASTM F1717)	Demonstrated performance substantially equivalent to predicate devices.
Nanotechnology Adherence/Performance
* Nanosurface characteristics (pore size diameter 30-90 nanometers)	The device's nano pedicle screw has a micro- and nano-roughened surface with electrochemically treated nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers, and calcium and phosphate incorporated into the nanotube surface. This confirms the stated nanotechnology characteristics.
* Mineralization of Extracellular Matrix (Osteoblasts & Mesenchymal Stem Cells)	In vitro study results demonstrated that the Nano FortiFix nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces. (This indicates it met the performance criteria for functional benefit related to the nanosurface.)
Biocompatibility/Safety
* Bacterial Endotoxin Testing (AAMI ST72:2011)	Bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit.
Substantial Equivalence	The Nano FortiFix® System possesses the same intended use and technological characteristics (performance, basic design, implant grade materials, and sizes) as the predicate devices. Therefore, Nano FortiFix® is substantially equivalent for its intended use.

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- For mechanical testing (ASTM F1717), the text mentions "worst case construct" but does not specify the numerical sample size (e.g., number of constructs tested for each type of loading or the number of repetitions for each test).
- For in vitro evaluations (mineralization), the text does not specify the numerical sample size (e.g., number of cell cultures, experimental replicates).
- For bacterial endotoxin testing, the text does not specify the numerical sample size (e.g., number of samples tested).
Data Provenance: The studies were conducted by the manufacturer as part of their 510(k) submission. The exact country of origin for the studies is not explicitly stated, but the sponsor's location (Nanovis Spine, LLC, Columbia City, Indiana, USA) suggests a U.S. origin. All studies appear to be prospective in nature, designed specifically to evaluate the Nano FortiFix® System.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the type of studies described. The studies are primarily in vitro (cell culture and mechanical testing) and material/biological safety analyses (bacterial endotoxin). There is no "ground truth" derived from human experts in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests comes from adherence to established standards (ASTM F1717, AAMI ST72:2011) and scientific principles for cell culture and material properties.

4. Adjudication method for the test set

This information is not applicable as the studies are not based on interpreting patient data where adjudication would be necessary. The results are quantitative measurements from laboratory tests.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a thoracolumbosacral pedicle screw system, an implantable medical device, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The type of ground truth used

For mechanical testing: The ground truth is established by the specified performance requirements of the ASTM F1717 standard and the comparative performance of legally marketed predicate devices. The "truth" is whether the device meets or exceeds these established benchmarks.
For nanotechnology/mineralization studies: The ground truth is the quantitative measurement of mineralization in cell cultures and the successful demonstration of the specified nanotopography. The comparison to "other surfaces" provides the baseline.
For bacterial endotoxin testing: The ground truth is defined by the "specified testing limit" within the AAMI ST72:2011 standard.

8. The sample size for the training set

Not applicable. This device is a physical implant, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning model, there is no ground truth established for a training set.

Summary

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22 December 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Nanovis LLC % Karen Warden President BackRoads Consulting, Inc. PO Box 566 Chesterland, Ohio 44026

Re: K203452

Trade/Device Name: Nano FortiFix Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: November 20, 2020 Received: November 23, 2020

Dear Karen Warden:

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

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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 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 (OS) 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 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,

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

510(k) Number (if known)

K203452

Device Name Nano FortiFix® System

Indications for Use (Describe)

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 7 – 510(k) Summary

Date:	20 November 2020
Sponsor:	Nanovis Spine, LLC5865 East State Rd. 14Columbia City, Indiana 46725 USA(877) 907-6266(260) 625-3834
Sponsor Contact:	Matthew Hedrick, CEO & Chief Operating Officer
510(k) Contact:	Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457
Proposed Trade Name:	Nano FortiFix® System
Common Name:	Posterior spinal system
Device Classification:	Class II
Classification Name:	Thoracolumbosacral pedicle screw system
Regulation:	888.3070
Device Product Code:	NKB
Submission Purpose:	The subject 510(k) adds non-modular polyaxial and monoaxial screws,rods, cross connectors, and set screws to the Nano FortiFix® System.
Device Description:	Nano FortiFix® is a posterior pedicle screw system consisting of rods,polyaxial and monoaxial pedicle screws, connectors and fasteners in avariety of sizes to accommodate differing anatomic requirements. The NanoFortiFix® pedicle screw shaft is available having a nanosurface.The Nano FortiFix® nano pedicle screw has a micro- and nano-roughenedsurface that demonstrates the requirements for nanotechnology. Thesurface of the nano screw threads has been deliberately manipulated toproduce nanoscale dimensions which exhibit specific properties. Thesethreads are electrochemically treated to possess a controllednanotopography composed of nanotube arrays having a pore size diameterbetween 30-90 nanometers. Calcium and phosphate are incorporated intothe nanotube surface.
Indications for Use:	The Nano FortiFix® System is intended to provide immobilization andstabilization of spinal segments in skeletally mature patients as an adjunctto fusion in the non-cervical spine for the following indications: DDD(defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spinal stenosis,spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ orlordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/orfailed previous fusion. The Nano FortiFix® System can be used in an openapproach or a percutaneous approach with MIS instrumentation.
Materials:	Nano FortiFix® System implants are manufactured from titanium alloy asdescribed by ASTM F136. Rods are additionally manufactured from cobaltchrome (ASTM F1537).
Primary Predicate:	Nano FortiFix® System (Nanovis Spine, LLC – K193211)
Additional Predicates:	Nanovis Spinal System (Nanovis LLC – K113173)Altus Spine Pedicle Screw System (Altus Partners, LLC – K181339)
Performance Data:	Mechanical testing of the worst case construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. The mechanical test results demonstrate that the Nano FortiFix® performance is substantially equivalent to the predicate devices. To address the “Points to Consider” in the FDA's Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, in vitro evaluations were performed to quantitate the mineralization of extracellular matrix secreted by osteoblasts (OB) and mesenchymal stem cells (MSC) on surfaces created from a titanium alloy substrate. The in vitro study results demonstrated that the Nano FortiFix nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces. In addition, bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit.
Technological Characteristics:	Nano FortiFix® possesses the same technological characteristics as the predicate devices. These include:performance (as described above), basic design (rod and screw system), implant grade materials (titanium alloy, cobalt chrome), and sizes (dimensions are within those offered by the predicates). Therefore the fundamental scientific technology of the Nano FortiFix® devices is the same as previously cleared devices.
Conclusion:	The Nano FortiFix® System possesses the same intended use and technological characteristics as the predicate devices. Therefore Nano FortiFix® is substantially equivalent for its intended use.

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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.