Hexanium TLIF

K210359 · Spinevision, S.A.S. · MAX · Mar 10, 2021 · Orthopedic

Device Facts

• Record ID: K210359
• Device Name: Hexanium TLIF
• Applicant: Spinevision, S.A.S.
• Product Code: MAX · Orthopedic
• Decision Date: Mar 10, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hexanium® TLIF (Transforaminal Lumbar Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Discase (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Hexanium® TLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via transforaminal approach. Hexanium® TLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

Device Story

Hexanium® TLIF is a titanium alloy (Ti6Al4V ELI) interbody cage produced via additive manufacturing; features honeycomb structure for bone through-growth and graft windows. Implanted via transforaminal approach in lumbar spine (L2-S1) to facilitate fusion; must be filled with autogenous bone graft and used with supplemental internal spinal fixation. Used by surgeons in clinical settings to treat discogenic back pain associated with DDD. Device provides structural support to intervertebral space; honeycomb design promotes osseointegration. Benefits include stabilization of spinal segment and potential reduction of pain.

Clinical Evidence

No clinical data has been presented. Evidence is based on bench testing (mechanical testing per ASTM F2077-14 and ASTM 2267-04) and FEA analysis comparing the subject device to the predicate worst-case construct.

Technological Characteristics

Material: Titanium alloy (Ti6Al4V ELI). Manufacturing: Additive manufacturing. Design: Honeycomb structure with bone graft windows; 5° lordosis angle. Dimensions: Heights 7-16mm; footprints 28x9mm to 32x10.5mm. Sterilization: Provided sterile. Standards: ASTM F2077-14, ASTM 2267-04, USP bacterial endotoxins.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1, including those with up to Grade I spondylolisthesis or retrolisthesis, who have failed at least 6 months 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

• Hexanium® TLIF (K180437)
• Nexxt Spine, LLC Matrixx™ System (K171140)

Submission Summary (Full Text)

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March 10, 2021

SpineVision SAS % Sevrina Ciucci Regulatory Affairs Consultant Lince Consulting LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583

Re: K210359

Trade/Device Name: Hexanium® TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 5, 2021 Received: February 8, 2021

Dear Sevrina Ciucci:

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/cdrl/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.

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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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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, 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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## Indications for Use

K210359

Device Name Hexanium® TLIF

#### Indications for Use (Describe)

The Hexanium® TLIF (Transforaminal Lumbar Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Discase (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Hexanium® TLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via transforaminal approach. Hexanium® TLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

Type of Use (*Select one or both, as applicable*)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(K) SUMMARY

| Date Prepared | February 5, 2021 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | SpineVision SAS<br>10 rue de la Renaissance<br>Batiment E<br>92160 Antony<br>FRANCE |
| Submitter Contact | Mr, Arnaud BRISARD<br>SpineVision CEO<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Correspondent<br>Contact | Sevrina Ciucci<br>Lincé Consulting, LLC<br>US Agent<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>Email: [e-mail]<br><br>Alternate Contact:<br>Nancy Lincé<br>Lincé Consulting, LLC<br>US Agent<br>Clinical and Regulatory Affairs Consultant<br>Phone: [phone]<br>Email: [e-mail] |
| Device Name | Hexanium® TLIF |
| Class | Class II |
| Product Code | MAX: Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification | 21 CFR§888.3080: Intervertebral body fusion device |
| Device Panel | Orthopedic |
| Primary Predicate | K180437 SpineVision SAS Hexanium® TLIF |
| Additional<br>Predicate | Nexxt Spine, LLC Matrixx™ System (K171140) |

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| Device Description | The Hexanium® TLIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage.<br>Hexanium® TLIF is available in a straight and curved shape in heights of 7mm to 16mm in 1mm increments in a Small footprint (28mm x 10mm) and a Medium footprint (32mm x 10mm) for the straight cage and a Small footprint (28mm x 9mm) and a Medium footprint (32mm x 10.5mm) for the curved cage. Hexanium® TLIF has a 5° Lordosis angle.<br>Hexanium® TLIF devices are provided sterile. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Hexanium® TLIF (Transforaminal Lumbar 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 or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Hexanium® TLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via transforaminal approach. Hexanium® TLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine. |
| Performance Data | The mechanical testing (according to ASTM 2267-04 and ASTM F2077-14) performed and submitted to support 510(k) clearance of the Hexanium TLIF system (K180437) also supports the subject Hexanium TLIF cages as demonstrated by mechanical and bone fusion worst-case FEA. The results demonstrate that the predicate Hexanium TLIF cage remains a worst-case construct as compared to the subject Hexanium TLIF cage. The predicate Hexanium TLIF (K180437) remains the worst-case construct for mechanical testing because, when compared to the subject cages, the previously tested Hexanium TLIF cage has the highest von mises stress in axial compression, compression shear, torsion, and expulsion.<br>Furthermore, the same predicate cage also has the smallest surface area between the bone graft and endplates and contains the lowest bone graft volume demonstrating it serves as the worst case for bone fusion. Finally, the predicate Hexanium TLIF (K180437) is the worst-case for cleaning and sterilization as is the most difficult-to-clean, has the largest surface area and volume, and has the heaviest weight.<br>The Hexanium® TLIF device conforms to the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device Document issued on June 12, 2007.<br>Bacterial Endotoxins Test was performed in accordance with USP to |
| | demonstrate that the device meets pyrogen limit specifications. |
| Clinical<br>Performance Data | No clinical data has been presented. |
| Substantial<br>Equivalence | The Hexanium® TLIF is substantially equivalent to the primary predicate<br>device in terms of intended use, design, mechanical properties, and<br>function. |
| Conclusion | The Hexanium® TLIF is substantially equivalent to the<br>predicate device. |

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