NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM

K110442 · Nanovis, LLC · ODP · Nov 9, 2011 · Orthopedic

Device Facts

• Record ID: K110442
• Device Name: NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM
• Applicant: Nanovis, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Nov 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System 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. 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 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). 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.

Device Story

System consists of intervertebral body fusion cages and surgical instruments; used for spinal fusion in cervical (C2-T1) and lumbar (L2-S1) regions. Implants fabricated from PEEK or titanium alloy (Ti-6Al-4V ELI). Cages implanted by surgeons during spinal fusion procedures to provide structural support while bone graft facilitates fusion. Used in conjunction with supplemental fixation hardware. Benefits include stabilization of spinal segments in patients with degenerative disc disease. Device is purely mechanical; no software or algorithmic components.

Clinical Evidence

Bench testing only. Performance evaluated via static and dynamic axial compression, static and dynamic torsion (ASTM F2077), subsidence (ASTM F2267), and expulsion (draft ASTM F04.25.02.02). No clinical data provided.

Technological Characteristics

Materials: PEEK and titanium alloy (Ti-6Al-4V ELI). Mechanical intervertebral body fusion cages. Testing standards: ASTM F2077, ASTM F2267, draft ASTM F04.25.02.02. No software, electronics, or energy sources.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease requiring spinal fusion at one level (C2-T1) or one/two contiguous levels (L2-S1). Cervical patients require 6 weeks non-operative treatment; lumbar patients require 6 months non-operative treatment. Lumbar patients may have prior non-fusion surgery or Grade 1 spondylolisthesis/retrolisthesis.

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

• LDR Spine Cervical Interbody Fusion System (K091088)
• Novel® Spinal Spacer System (K081730)
• Choice Spine Cervical Interbody Spacer System (K091531)
• CORNERSTONE® PSR Spinal System (K100214)
• Synthes Oracle Spacer (K072791)
• L-Varlock Lumbar Cage (K080537)
• WAVE and LOOP Cages (K080401)
• Ardis Spacer (K073202)
• Lumbar I/F Cage with VSP Spine System (P960025)
• Spinal USA Intervertebral Body Fusion Device (K080314, K081196, K092193)

Submission Summary (Full Text)

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Nanovis Intervertebral Body Fusion System

## 510(k) Summary

# Nanovis, LLC

# Nanovis Intervertebral Body Fusion System

### K110442

November 2, 2011

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Nanovis, LLC<br>5865 East State Road 14<br>Columbia City, IN 46725 |
|--------------------|--------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |

Official Contact:

Representative/Consu

Matt Hedrick President and Chief Operating Officer [e-mail]

| ultant: | Kevin A. Thomas, PhD |
|---------|-------------------------------------------------|
| | Floyd G. Larson |
| | PaxMed International, LLC |
| | 11234 El Camino Real, Suite 200 |
| | San Diego, CA 92130 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail]<br>[e-mail] |

## DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name:

Classification Regulations: Product Code:

Classification Panel: Reviewing Branch:

Nanovis Intervertebral Body Fusion System Intervertebral body fusion device Intervertebral body fusion device

21 CFR 888.3080, Class II ODP, MAX

Orthopedic and Rehabilitation Devices Panel Orthopedic Spine Devices Branch

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#### 510(k) Summary K110442

Nanovis Intervertebral Body Fusion System

#### INTENDED USE

When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System 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. 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 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). 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.

#### DEVICE DESCRIPTION

.

The Nanovis Intervertebral Body Fusion System consists of implants (cages) and related instruments intended to be used for intervertebral body fusion procedures involving the cervical (C2 - T1) and lumbar (L2 - S1) spine. The cages are available in a variety of shapes and sizes to accommodate the individual anatomic and clinical circumstances of each patient, and are available in two materials: polyetheretherketone (PEEK) and titanium alloy (Ti-6AI-4V ELI).

## EQUIVALENCE TO MARKETED DEVICE

Nanovis, LLC submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the Nanovis Intervertebral Body Fusion System is substantially equivalent in indications and design principles to the following predicate devices each of which has been determined by FDA to be substantially equivalent to preamendment devices, or that were the subject of approved PMA applications and were subsequently reclassified as Class II devices:

LDR Spine Cervical Interbody Fusion System from LDR Spine USA, K091088; Novel® Spinal Spacer System from Alphatec Spine, Inc., K081730; Choice Spine Cervical Interbody Spacer System from Choice Spine, LP, K091531; CORNERSTONE® PSR Spinal System from Medtronic Sofamor Danek, K100214; Synthes Oracle Spacer from Synthes Spine, K072791;

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L-Varlock Lumbar Cage from Kiscomedica, S.A., K080537; WAVE and LOOP Cages from Advanced Medical Technologies AG, K080401; Ardis Spacer from Abbot Spine, Inc. (now Zimmer Spine), K073202; Lumbar I/F Cage with VSP Spine System from DePuy AcroMed, P960025; and Spinal USA Intervertebral Body Fusion Device from Spinal USA, K080314, K081196, and K092193.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of the same materials, have similar overall shape, and encompass the same range of physical dimensions including height, width, depth, and lordosis. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. Any differences in technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.

Performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 (static and dynamic axial compression, and static and dynamic torsion), ASTM F2267 (subsidence), and the draft standard ASTM F04.25.02.02 (expulsion).

Overall, the Nanovis Intervertebral Body Fusion System is similar to the predicate devices in intended use, design principles, materials and overall dimensions.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

NOV - 9 2011

Nanovis, LLC % PaxMed International, LLC Kevin A. Thomas, PhD 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K110442

Trade/Device Name: Nanovis Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: October 04, 2011 Received: October 04, 2011

Dear Dr. Thomas:

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

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Page 2 -- Kevin A. Thomas, PhD

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Erine Keith

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

Enclosure

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### Indications for Use

510(k) Number:

X 110442

Device Name:

Nanovis Intervertebral Body Fusion System

Indications for Use:

When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System 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. 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 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-SI. 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). 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

*(Division Sign-Off)*

Division of Surgical, Orthopedic, and Restorative Devices

KII0442 510(k) Number_