When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.

When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc 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 I spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

When used as a cervical intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.

When used as a lumbar intervertebral body fusion device, FortiCore® is 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). FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

Device Description

The Nanovis Intervertebral Body Fusion and FortiCore® Systems include PLIF implants and related instruments for implantation. The upper and lower aspects of the implants from both systems are open and have a central column to be packed with autogenous bone graft. The FortiCore® implants have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The PLIF devices from both systems are available in a variety of shapes and sizes to accommodate the individual patient anatomy. The Nanovis Intervertebral Body Fusion System and FortiCore® PLIF implants are offered as sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Nanovis Intervertebral Body Fusion System and FortiCore®. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance as would be expected for a novel AI/medical device.

Therefore, many of the requested categories related to AI/algorithm performance and clinical study details are not applicable to this submission. This is a common characteristic of 510(k) submissions for devices that are evolutionary rather than revolutionary, where the primary goal is to show similarity to existing, legally marketed products.

Here's the information extracted and, where applicable, noted as "N/A" for "Not Applicable" given the context of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: Static and dynamic compression testing per ASTM F2077.	The results demonstrated the performance of the modified Nanovis Intervertebral Body Fusion System and modified FortiCore devices are substantially equivalent to the predicate devices.
Biocompatibility/Sterility: Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011, with an endotoxin limit of 2.15 EU/mL.	BET results confirmed an endotoxin limit of 2.15 EU/mL was met.
Technological Characteristics: Must be similar to predicate devices in performance, basic design (hollow structural frame), implant grade materials (PEEK polymer, tantalum and/or titanium), and sizes (widths, lengths, heights within predicate ranges).	The modified Nanovis Intervertebral Body Fusion System and FortiCore® possess technological characteristics similar to the predicate devices, including performance (as described for mechanical testing), basic design, implant grade materials, and sizes.

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

Sample Size (Test Set): Not specified in terms of number of actual device units tested, but references "dimensional analyses of the modified Nanovis Intervertebral Body Fusion and FortiCore® devices".
Data Provenance: N/A for clinical data, as this is a mechanical and material performance study, not a clinical trial. The study was conducted by the manufacturer to demonstrate substantial equivalence.

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

N/A. Ground truth in this context refers to mechanical and material standards (ASTM and ANSI/AAMI), not expert clinical consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. This is a technical performance study against specified standards, not a clinical study requiring human reader adjudication.

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

N/A. This document pertains to an intervertebral body fusion device, not an AI-assisted diagnostic or therapeutic tool.

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

N/A. This document pertains to an intervertebral body fusion device, not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth relies on established engineering standards (ASTM F2077 for mechanical testing, ANSI/AAMI ST-72:2011 for bacterial endotoxin testing) and comparison to the characteristics of legally marketed predicate devices.

8. The sample size for the training set

N/A. No training set is relevant for this type of mechanical and material characteristics study.

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

N/A. No training set is relevant for this type of mechanical and material characteristics study.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three faces overlapping to create a sense of depth and dimension. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

Nanovis, LLC % Karen E. Warden, Ph.D. President Backroads Consulting, Incorporated P.O. Box 566 Chesterland. Ohio 44026

Re: K161485

Trade/Device Name: Nanovis Intervertebral Body Fusion System and Forticore® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OPD Dated: August 8. 2016 Received: August 10, 2016

Dear Dr. 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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161485

Device Name

Nanovis Intervertebral Body Fusion System

Indications for Use (Describe)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161485

Device Name FortiCore®

Indications for Use (Describe)

When used as a cervical intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.

When used as a lumbar intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc 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). FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Date:	1 September 2016
Sponsor:	Nanovis Spine, LLC5865 East State Rd. 14Columbia City, Indiana 46725 USA(877) 907-6266
Sponsor Contact:	Matthew Hedrick, CEO & Chief Operating Officer
510(k) Contact:	Karen E. Warden, PhDBackRoads ConsultingPO Box 566Chesterland, OH 44026Office: 440.729.8457
Trade Names:	Nanovis Intervertebral Body Fusion System and FortiCore®
Common Name:	Interbody fusion device
Device Classification	Class II
Classification Name:	Intervertebral body fusion device
Regulation:	888.3080
Device Product Code:	MAX, ODP
Submission Purpose:	To add sizes and modify the external shape of the Nanovis IntervertebralBody Fusion and FortiCore® System PLIF implants, and to provide theNanovis Intervertebral Body Fusion PLIF implants as sterile packaged.
Device Description:	The Nanovis Intervertebral Body Fusion and FortiCore® Systems includePLIF implants and related instruments for implantation. The upper and loweraspects of the implants from both systems are open and have a centralcolumn to be packed with autogenous bone graft. The FortiCore® implantshave an integrated titanium scaffold which assists in securing the implant inthe intervertebral space. The PLIF devices from both systems are available ina variety of shapes and sizes to accommodate the individual patient anatomy.The Nanovis Intervertebral Body Fusion System and FortiCore® PLIFimplants are offered as sterile.
Intended Use:	When used as a cervical intervertebral body fusion device, the NanovisIntervertebral Body Fusion System is intended for spinal fusion procedures inskeletally mature patients with degenerative disc disease (defined as neckpain of discogenic origin with degeneration of the disc confirmed by historyand radiographic studies) at one spinal level from C2-T1. These patientsshould have had at least six weeks of non-operative treatment. NanovisIntervertebral Body Fusion System implants are to be used with autogenousbone graft and in combination with supplemental fixation indicated for cervicalfusion procedures.When used as a lumbar intervertebral body fusion device, the NanovisIntervertebral Body Fusion System is intended for spinal fusion procedures inskeletally mature patients with degenerative disc disease (defined asdiscogenic back pain with degeneration of the disc confirmed by history andradiographic studies) at one or two contiguous spinal levels from L2-S1.These patients should have had six months of nonoperative treatment. Thesepatients may have had a previous non-fusion spinal surgery and/or may haveup to Grade I spondylolisthesis or retrolisthesis at the involved spinal level(s).Nanovis Intervertebral Body Fusion System implants are to be used withautogenous bone graft and in combination with supplemental fixationindicated for lumbar spinal fusion procedures.
Intended Use:	When used as a cervical intervertebral body fusion device, FortiCore® isintended for spinal fusion procedures in skeletally mature patients withdegenerative disc disease (defined as neck pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies) atone spinal level from C2-T1. These patients should have had at least sixweeks of non-operative treatment. FortiCore® devices are to be used withautogenous bone graft and in combination with supplemental fixationindicated for cervical fusion procedures.When used as a lumbar intervertebral body fusion device, FortiCore® isintended for spinal fusion procedures in skeletally mature patients withdegenerative disc disease (defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographic studies) atone or two contiguous spinal levels from L2-S1. These patients should havehad six months of nonoperative treatment. These patients may have had aprevious non-fusion spinal surgery and/or may have up to Grade 1spondylolisthesis or retrolisthesis at the involved spinal level(s). FortiCore®devices are to be used with autogenous bone graft and in combination withsupplemental fixation indicated for lumbar spinal fusion procedures.
Materials:	The Nanovis Intervertebral Body Fusion System implants are available inpolyetheretherketone (PEEK- OPTIMA® LT1, Invibio® as described by ASTMF2026) and titanium alloy (Ti-6Al-4V ELI as described by ASTM F136). ThePEEK devices incorporate a tantalum marker per ASTM F560.FortiCore® devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio®) as described by ASTM F2026. The integratedscaffold (BioSync-Ti, Sites Medical) is manufactured from CP titanium asdescribed by ASTM F67. The FortiCore® devices also incorporate a tantalummarker per ASTM F560.
Primary Predicate:	Nanovis Intervertebral Body Fusion System (Nanovis LLC, K110442)
Additional Predicates:	FortiCore® (Nanovis LLC, K140280)Aleutian® IBF System (K2M, Inc., K133614)
Performance Data:	Static and dynamic compression testing per ASTM F2077 and/or dimensionalanalyses of the modified Nanovis Intervertebral Body Fusion and FortiCore®devices were performed. The results demonstrated the performance of themodified Nanovis Intervertebral Body Fusion System and modified FortiCoredevices are substantially equivalent to the predicate devices. In addition,bacterial endotoxin testing (BET) has been performed. BET as specified inANSI/AAMI ST-72:2011 confirm an endotoxin limit of 2.15 EU/mL.
TechnologicalCharacteristics:	The modified Nanovis Intervertebral Body Fusion System and FortiCore®possess technological characteristics similar to the predicate devices. Theseinclude:● performance (as described above),● basic design (hollow structural frame),● implant grade materials (PEEK polymer, tantalum and/or titanium), and● sizes (widths, lengths and heights are within the range(s) offered by thepredicates).Therefore the fundamental scientific technology of the FortiCore devices isthe similar to previously cleared devices.
Conclusion:	The Nanovis Intervertebral Body Fusion System and FortiCore® possess thesame intended use and similar technological characteristics as the predicatedevices. Therefore the Nanovis Intervertebral Body Fusion System andFortiCore® are substantially equivalent to legally marketed predicates.

510(k) Summary

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.