(30 days)
No
The summary describes a physical intervertebral body fusion device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is an intervertebral body fusion device indicated for use in patients with Degenerative Disc Disease (DDD) to promote spinal fusion, which is a therapeutic purpose.
No
The Hexanium® TLIF system is an intervertebral body fusion device, which is an implant used for surgical treatment, not for diagnosing a condition. Its purpose is to aid in fusion after bone graft placement.
No
The device description clearly states it is a titanium alloy interbody cage, which is a physical hardware implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Hexanium® TLIF system is an intervertebral body fusion device used for surgical implantation in patients with Degenerative Disc Disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium alloy, designed to be placed between vertebrae. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Hexanium® TLIF system is a device implanted into the body to treat a condition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
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.
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.
Hexanium® TLIF devices are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
The Hexanium® TLIF device conforms to the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device Document issued on June 12, 2007.
Bacterial Endotoxins Test was performed in accordance with USP to demonstrate that the device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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 |
| 10 rue de la Renaissance | |
| Batiment E | |
| 92160 Antony | |
| FRANCE | |
| Submitter Contact | Mr, Arnaud BRISARD |
| SpineVision CEO | |
| Tel: +33 1 53 33 25 25 | |
| Fax: +33 1 72 69 00 30 | |
| Email: a.brisard@spinevision.com | |
| Correspondent | |
| Contact | Sevrina Ciucci |
| Lincé Consulting, LLC | |
| US Agent | |
| Regulatory Affairs Consultant | |
| Phone: (408) 316-4837 | |
| Email: sciucci@linceconsulting.com |
Alternate Contact:
Nancy Lincé
Lincé Consulting, LLC
US Agent
Clinical and Regulatory Affairs Consultant
Phone: (650) 759-6186
Email: nlince@linceconsulting.com |
| 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
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.
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.
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.
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.
The Hexanium® TLIF device conforms to the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device Document issued on June 12, 2007.
Bacterial Endotoxins Test was performed in accordance with USP to |
| | demonstrate that the device meets pyrogen limit specifications. |
| Clinical
Performance Data | No clinical data has been presented. |
| Substantial
Equivalence | The Hexanium® TLIF is substantially equivalent to the primary predicate
device in terms of intended use, design, mechanical properties, and
function. |
| Conclusion | The Hexanium® TLIF is substantially equivalent to the
predicate device. |
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