Hexanium ACIF

K221578 · Spinevision, S.A.S. · OVE · Nov 14, 2022 · Orthopedic

Device Facts

• Record ID: K221578
• Device Name: Hexanium ACIF
• Applicant: Spinevision, S.A.S.
• Product Code: OVE · Orthopedic
• Decision Date: Nov 14, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received at least 6 weeks of non-operative treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.

Device Story

Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via additive manufacturing; features honeycomb structure for bone through-growth and lateral/vertical bone graft windows. Implanted via anterior approach to facilitate fusion in cervical spine. System includes reusable surgical instruments. Device is filled with autogenous bone graft. Used by surgeons in clinical settings to treat discogenic neck pain. Modifications in this submission are limited to surgical instruments; implantable components remain unchanged from predicate.

Clinical Evidence

No clinical data presented. Substantial equivalence supported by bench testing of modified surgical instruments.

Technological Characteristics

Material: Ti6Al4V ELI titanium alloy. Manufacturing: Additive manufacturing. Structure: Honeycomb with bone graft windows. Dimensions: Heights 5-12mm, footprints 15x12mm, 17x14mm, 19x15mm. Profiles: Lordotic 6º, convex 6º. Screws: Self-drilling, 10-16mm lengths, 3.50/3.80mm diameters. Sterilization: Provided sterile. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1, including those with up to Grade I spondylolisthesis or retrolisthesis, who have failed at least 6 weeks of non-operative treatment.

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

• SpineVision SAS Hexanium ACIF (K193000)

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 14, 2022

SpineVision, S.A.S. % Ms. Nancy Lincé President and CEO Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583

Re: K221578

Trade/Device Name: Hexanium® ACIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: October 21, 2022 Received: October 24, 2022

Dear Ms. Lincé:

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

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

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 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 (QS) 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,

Brent Showalter -S

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

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

## Indications for Use

510(k) Number (if known) K221578

Device Name Hexanium® ACIF

#### Indications for Use (Describe)

The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received at least 6 weeks of non-operative treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.

| Type of Use (Select one or both, as applicable) | | | | | | | | | |
|-------------------------------------------------|--|--|---------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------|--|--|--|--|
| | | | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | | and the comments of the comments of the comments of the comments of the comments of | | | | |

X Prescription Use (Part 21 CFR 801 Subpart D)

__ 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 PRAStaff(@fda.hhs.gov

"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}------------------------------------------------

#

| Date Prepared | October 21, 2022 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | SpineVision SAS<br>10 rue de la Renaissance<br>Batiment E<br>92160 Antony<br>FRANCE |
| Submitter Contact | Quang Tran<br>Director, Quality Assurance & Regulatory Affairs<br>Tel: [phone]<br>Email: [e-mail] |
| Correspondent<br>Contact | Nancy Lincé<br>Lincé Consulting, LLC<br>US Agent<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>Email: [e-mail] |
| Device Name | Hexanium® ACIF |
| Class | Class II |
| Product Code | OVE: Intervertebral Fusion Device with integrated fixation, cervical |
| Classification | 21 CFR 888.3080: Intervertebral body fusion device |
| Device Panel | Orthopedic |
| Primary Predicate | SpineVision SAS Hexanium ACIF (K193000) |
| Device Description | The Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage<br>manufactured via an Additive Manufacturing method. The honeycomb<br>structure allows for bone through-growth through the structure of the device<br>as well as providing lateral and vertical bone graft windows in the body of<br>the cage. Hexanium® ACIF is available in 2 sagittal profiles (lordotic 6º and<br>convex 6°), heights of 5-12 mm, and 3 footprints (15x12mm, 17x14mm,<br>and 19x15mm). The Hexanium® ACIF screws are self-drilling and<br>available in lengths of 10, 12, 14, and 16mm and diameters of 3.50 and<br>3.80mm. Hexanium® ACIF is provided sterile. The Hexanium® ACIF<br>system includes a set of reusable surgical instruments. The purpose of this<br>Special 510(k) application is to propose minor modifications to the currently<br>cleared surgical instruments. There are no modifications being proposed for<br>the implantable components of the system |
| Indications for Use | The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is<br>an intervertebral body fusion device indicated for use with autogenous<br>bone graft in skeletally mature patients with Degenerative Disc Disease<br>(DDD) at one level from C3-T1. DDD is defined as discogenic neck<br>pain with degeneration of the disc confirmed by patient history and<br>radiographic studies. These DDD patients may also have up to Grade I<br>spondylolisthesis or retrolisthesis at the involved level(s). Patients<br>should have received at least 6 weeks of non-operative treatment prior<br>to treatment with Hexanium® ACIF system. This device has to be filled<br>with autogenous bone graft material. This device is implanted via an<br>anterior approach. |
| Performance Data | Appropriate supportive testing and evaluations were conducted on the<br>Hexanium ACIF surgical instruments to demonstrate that they meet<br>product specifications, pertinent standards, medical community's<br>expectations, and product labeling. These evaluations have shown that<br>the modified instrument configurations meet the same pre-determined<br>functional and performance requirements and external standard<br>requirements as the predicate instruments and are substantially<br>equivalent. The Hexanium ACIF implants are unchanged from the<br>predicate and continue to meet special controls FDA guidance<br>"Guidance for Industry and FDA Staff – Class II Special Controls<br>Guidance Document: Intervertebral Body Fusion Device" dated June<br>12, 2007. |
| Clinical<br>Performance Data | No clinical data has been presented. |
| Substantial<br>Equivalence<br>Conclusion | The Hexanium® ACIF is substantially equivalent to the predicate device in<br>terms of intended use, design, mechanical properties, and function.<br>The Hexanium® ACIF is substantially equivalent to the<br>predicate device. |

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