Anatomic PEEK™ Cervical Fusion System with Nanotechnology

K230936 · Nanovis, LLC · ODP · Jun 2, 2023 · Orthopedic

Device Facts

• Record ID: K230936
• Device Name: Anatomic PEEK™ Cervical Fusion System with Nanotechnology
• Applicant: Nanovis, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jun 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Anatomic PEEK™ Cervical Fusion System with Nanotechnology devices including those with macro-, micro-, and nanoroughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of non-operative treatment. The Anatomic PEEK™ device is to be used with supplemental fixation; the hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. The Anatomic PEEK™ Cervical Fusion System with Nanotechnology is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, and is to be implanted via an open anterior approach.

Device Story

Intervertebral body fusion device; PEEK implant with integrated titanium scaffold; scaffold features macro-, micro-, and nanoroughened surface textures; nanotopography consists of electrochemical nanotube arrays (30-90 nm diameter) with incorporated calcium and phosphate. Implanted via open anterior approach by surgeons to treat cervical disc degeneration/instability. Scaffold assists in implant fixation and provides radiographic visualization. Used with supplemental fixation and bone graft to promote fusion. Benefits include stabilization of spinal segments and potential for improved osseointegration via nanostructured surface.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077 (static/dynamic axial compression and torsion), ASTM F2267 (subsidence), and expulsion testing. MR compatibility testing performed per ASTM F2503. No clinical data provided.

Technological Characteristics

Implants: PEEK-OPTIMA LT1 (ASTM F2026). Scaffold: CP Titanium Grade 2 (ASTM F67) with 523 µm pores and 229 µm interconnections. Surface: Electrochemical nanotube arrays (30-90 nm) with calcium/phosphate. Instruments: Stainless steel (ASTM F899) with silicone handles. Mechanical fixation required.

Indications for Use

Indicated for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration or spinal instability (confirmed by imaging) resulting in radiculopathy or pain at C2-T1 levels. Requires at least six weeks of failed non-operative treatment. Must be used with supplemental fixation (anterior cervical plate for hyperlordotic implants) and bone graft (autogenous, allograft, or demineralized allograft with bone marrow aspirate).

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

• Nano FortiCore® (K191822)
• Cascadia Interbody System (K160125)
• MC+ (K091088)
• Anatomic PEEK™ Cervical Fusion System (K192502)

Submission Summary (Full Text)

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June 2, 2023

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K230936

Trade/Device Name: Anatomic PEEK™ Cervical Fusion System with Nanotechnology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 31, 2023 Received: April 3, 2023

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

Sincerely,

Katherine D. Kavlock -S

for Brent Showalter, Ph.D. 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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

## Indications for Use

510(k) Number (if known) K230936

#### Device Name

Anatomic PEEKIM Cervical Fusion System with Nanotechnology

#### Indications for Use (Describe)

Anatomic PEEK™ Cervical Fusion System with Nanotechnology devices including those with macro-, micro-, and nanoroughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of non-operative treatment. The Anatomic PEEK™ device is to be used with supplemental fixation; the hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. The Anatomic PEEK™ Cervical Fusion System with Nanotechnology is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, and is to be implanted via an open anterior approach.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 5px;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
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# 510(k) Summary

| Date: | 31 May 2023 |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Nanovis Spine, LLC |
| | 5865 East State Rd. 14 |
| | Columbia City, Indiana 46725 USA |
| | [phone] |
| | [phone] |
| Sponsor Contact: | Brian More, CEO |
| 510(k) Contact: | Karen E. Warden, PhD |
| | BackRoads Consulting Inc. |
| | PO Box 566 |
| | Chesterland, OH 44026 |
| | Office: 440.729.8457 |
| Proposed Trade Name: | Anatomic PEEK™ Cervical Fusion System with Nanotechnology |
| Common Name: | Cervical interbody fusion device |
| Device Classification: | Class II |
| Classification Name,<br>Regulation Number,<br>Product Code: | Intervertebral fusion device with bone graft, cervical, 888.3080, ODP |
| Device Description: | The Anatomic PEEK™ Cervical Fusion System with Nanotechnology |
| | consists of implants and instruments for implantation. The upper and lower<br>surfaces of the implant incorporate a three-dimensional titanium scaffold |
| | with interconnected pores averaging 523 µm, and pore interconnections<br>averaging 229 µm 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 Anatomic |
| | PEEK™ devices is electrochemically treated to possess a controlled<br>nanotopography composed of nanotube arrays having a pore size diameter |
| | between 30-90 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 Anatomic PEEK™ devices are available in a variety of sizes to<br>accommodate the individual anatomic and clinical circumstances of each |
| | patient. |
| Indications for Use: | Anatomic PEEK™ Cervical Fusion System with Nanotechnology devices |
| | including those with macro-, micro-, and nano-roughened surface textured |
| | features are indicated for use for anterior cervical interbody fusion in |
| | skeletally mature patients with cervical disc degeneration and/or cervical<br>spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), |
| | that results in radiculopathy, myelopathy, and/or pain at multiple contiguous |
| | levels from C2 to T1. These patients should have had at least six weeks of |
| | non-operative treatment. The Anatomic PEEK™ device is to be used with |
| | supplemental fixation; the hyperlordotic implants (≥ 10°) are required to be<br>used with an anterior cervical plate. The Anatomic PEEK™ Cervical Fusion |
| | System with Nanotechnology is also required to be used with autogenous |
| | bone and/or allograft bone graft comprised of cancellous and/or |
| | corticocancellous bone graft, and/or demineralized allograft bone with bone |
| | marrow aspirate, and is to be implanted via an open anterior approach. |
| Materials: | The Anatomic PEEK™ implants are manufactured from<br>polyetheretherketone (PEEK-OPTIMA® LT1) per ASTM F2026. The integral<br>scaffold (OsteoSync) is manufactured from CP titanium (Grade 2) as<br>described by ASTM F67. Instruments are manufactured from medical grade<br>stainless steel per ASTM F899 and include silicone handles. |
| Primary Predicate: | Nano FortiCore® (Nanovis, LLC – K191822) |
| Additional Predicate: | Cascadia Interbody System (K2M, Inc. – K160125), MC+ (LDR Holding,<br>K091088), Anatomic PEEK™ Cervical Fusion System (Medtronic Sofamor<br>Danek USA, Inc. – K192502) |
| Performance Data: | Mechanical testing of the worst case Anatomic PEEK™ implants included<br>static and dynamic axial compression and static and dynamic torsion<br>according to ASTM F2077. In addition, subsidence tests according to ASTM<br>F2267 and expulsion tests were performed.<br>The mechanical test results demonstrate that the Anatomic PEEK™<br>performance is substantially equivalent to the predicate devices.<br>Additionally, MR Compatibility testing per ASTM F2503 was performed. The<br>results demonstrate that the Anatomic PEEK™ implants can be safely<br>scanned in an MR system. |
| Technological<br>Characteristics: | The Anatomic PEEK™ Cervical Fusion System with Nanotechnology<br>possesses the same technological characteristics as one or more of the<br>predicate devices. These include:<br>basic design (structural column),material (reinforced polymer) andsizes (comparable to those offered by the predicates)Therefore the fundamental scientific technology of the Anatomic PEEK™<br>Cervical Fusion System with Nanotechnology is the same as previously<br>cleared devices. |
| Conclusion: | The Anatomic PEEK™ Cervical Fusion System with Nanotechnology<br>possesses the same intended use and technological characteristics as the<br>predicate devices. Therefore the Anatomic PEEK™ Cervical Fusion System<br>with Nanotechnology is substantially equivalent for its intended use. |

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