Nano FortiCore, FortiCore

K191822 · Nanovis, LLC · ODP · Oct 11, 2019 · Orthopedic

Device Facts

• Record ID: K191822
• Device Name: Nano FortiCore, FortiCore
• Applicant: Nanovis, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Oct 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nano FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® lumbar devices are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, Nano FortiCore® lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Nano FortiCore® lumbar devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

Device Story

Intervertebral body fusion devices (cervical and lumbar) designed to facilitate spinal fusion; implanted by surgeons during spinal fusion procedures. Devices consist of PEEK structural frame with integrated 3D titanium scaffold on upper/lower surfaces. Nano FortiCore® variant features electrochemically treated nanotube arrays (60-80 nm) on titanium scaffold, incorporating calcium and phosphate to assist in implant fixation and provide radiographic visibility. Used with autogenous/allogeneic bone graft and supplemental fixation. Benefits include structural support for intervertebral space and enhanced surface properties for bone mineralization. No software or algorithm involved.

Clinical Evidence

No clinical data. Evidence consists of bench testing (ASTM F2077, ASTM F2267) for mechanical integrity (static/dynamic compression, shear, torsion, subsidence, expulsion) and in vitro evaluations comparing mineralization of extracellular matrix on nanotube-treated surfaces versus control surfaces. Bacterial endotoxin testing performed per AAMI ST72:2011.

Technological Characteristics

Materials: PEEK (ASTM F2026), CP Titanium (ASTM F67), Tantalum (ASTM F560). Design: Hollow structural frame with 3D titanium scaffold (523 µm pores). Nano FortiCore® features electrochemical nanotube arrays (60-80 nm) with calcium phosphate. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for skeletally mature patients requiring anterior cervical spinal fusion (C2-T1) for disc degeneration/instability with radiculopathy, myelopathy, or pain (after 6 weeks non-operative treatment); or lumbar spinal fusion (L2-S1) for degenerative disc disease (after 6 months non-operative treatment), including patients with prior non-fusion surgery, Grade 1 spondylolisthesis/retrolisthesis, or degenerative scoliosis.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• FortiCore® (K171312)
• FortiCore® & Nanovis Interbody (K140280, K160874, K161485, K110442)
• ALTA Anterior Cervical Interbody Spacer (K173324)
• MC+ (K091088)
• Lumbar I/F Cage® (P960025)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name in a smaller font below.

October 11, 2019

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

Re: K191822

Trade/Device Name: Nano FortiCore®, FortiCore® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: September 18, 2019 Received: September 20, 2019

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

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

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K191822

Device Name FortiCore®

Indications for Use (Describe)

FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

| Type of Use (Select one or both, as applicable) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"> ☒ </span> Prescription Use (Part 21 CFR 801 Subpart D) </td><td><span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"> ☒ </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"> ☒ </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

[e-mail]

*"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."*

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K191822

Device Name Nano FortiCore®

#### Indications for Use (Describe)

Nano FortiCore® cervical devices are interior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nano FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

Nano FortiCore® lumbar devices are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radios) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, Nano FortiCore® lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Nano FortiCore® lumbar devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

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

| <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|

**CONTINUE ON A SEPARATE PAGE IF NEEDED.**

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 |
| [e-mail] |

*"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."*

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

# 510(k) Summary

| Date: | 5 July 2019 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Nanovis, LLC |
| | 5865 East State Rd. 14 |
| | Columbia City, Indiana 46725 USA |
| | [phone] |
| | [phone] |
| Contact: | Matthew Hedrick, CEO & Chief Operating Officer |
| Trade Names: | FortiCore® and Nano FortiCore® |
| Common Name: | Interbody fusion device |
| Device Classification | Class II |
| Classification Names: | Intervertebral body fusion device with bone graft, cervical & Intervertebral body fusion device with bone graft, lumbar |
| Regulation, Product Codes: | 21 CFR 888.3080, ODP & MAX |
| Device Description: | FortiCore® and Nano FortiCore® consist of implants and instruments for implantation. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 µm, and pore interconnections averaging 229 um in diameter. |
| | This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Nano FortiCore® devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having an average pore size between 60-80 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The FortiCore® and Nano FortiCore® devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. |
| Indications for Use: | FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nano FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® lumbar devices are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and |
| | radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, Nano FortiCore® lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Nano FortiCore® lumbar devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures. |
| Materials: | FortiCore® and Nano FortiCore® devices are manufactured from PEEK (OPTIMA® LT1, Invibio®) as described by ASTM F2026. The integrated scaffold (BioSync-Ti, Sites Medical) is manufactured from CP titanium as described by ASTM F67. Calcium phosphate is attached to the nanotubes. Marker pins in the lumbar devices are manufactured from tantalum per ASTM F560. |
| Primary predicate: | FortiCore® (Nanovis LLC, K171312) |
| Additional predicates: | FortiCore® & Nanovis Interbody (Nanovis LLC, K140280, K160874 & K161485, K110442), ALTA Anterior Cervical Interbody Spacer (Astura Medical, K173324), MC+ (LDR Holding, K091088), Lumbar I/F Cage® (DePuy AcroMed, Inc., P960025) |
| Performance Data: | Mechanical testing of the worst case FortiCore® and Nano FortiCore® devices was performed according to ASTM F2077 and included static and dynamic compression, static and dynamic compression shear and static and dynamic torsion. In addition, subsidence per ASTM F2267 and expulsion tests were performed. The mechanical test results demonstrate the FortiCore® and Nano FortiCore® device performance is substantially equivalent to the predicate devices.<br><br>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 and mesenchymal stem cells (MSCs) on surfaces created from a commercially pure titanium substrate. The in vitro study results demonstrated that the surface having Nanovis nanotube arrays develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces.<br><br>In addition, bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit. |
| Technological Characteristics: | FortiCore® and Nano FortiCore® possess the same technological characteristics as the predicate devices. These include:<br>• performance (as described above),<br>• basic design (hollow structural frame),<br>• implant grade materials (PEEK polymer and titanium), and<br>• sizes (widths, lengths and heights are within the range(s) offered by the predicates).<br>Therefore the fundamental scientific technology of the Nano FortiCore® devices is the same as previously cleared devices. |
| Conclusion: | FortiCore® and Nano FortiCore® possesses the same intended use and technological characteristics as the predicate devices. Therefore FortiCore® and Nano FortiCore® are substantially equivalent for their intended use. |

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