(73 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of an interbody fusion cage, with no mention of AI or ML technology.
Yes
The device is used to treat Degenerative Disc Disease (DDD) by promoting intervertebral body fusion, which is a therapeutic purpose.
No
This device is an implantable intervertebral body fusion device used in the treatment of Degenerative Disc Disease, not for diagnosis.
No
The device description clearly states it is a titanium alloy interbody cage, which is a physical implantable hardware device, not software.
Based on the provided information, the Hexanium® TLIF system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Hexanium® TLIF Function: The Hexanium® TLIF system is an implantable medical device used for spinal fusion. It is surgically placed inside the patient's body to provide structural support and promote bone growth between vertebrae.
The description clearly outlines its use in a surgical procedure for treating Degenerative Disc Disease, not for analyzing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Hexanium® TLIF (Transformational 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
MAX
Device Description
The Hexanium® TLIF device 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 heights of 7mm to 16mm in 1mm increments in a Small footprint (28mm X 9mm) or a Medium footprint (32mm X 10.5mm). 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 (lumbar spine)
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 Hexanium® TLIF device conforms to the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device Document issued on June 12, 2007.
Mechanical testing includes static compression, dynamic compression, static compression shear and dynamic compression shear performed according to ASTM F2077-14, subsidence testing performed according to ASTM 2267-04 and expulsion testing.
Mechanical testing was performed in a side-by-side comparison to the predicate device.
Results demonstrate comparable mechanical properties to the predicate device.
Bacterial Endotoxins Test was performed in accordance to USP to demonstrate that the device meets pyrogen limit specifications.
No clinical data has been presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image contains 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 4, 2018
SpineVision, SAS % Mr. Donald Guthner Regulatory Consultant Orgenix LLC 111 Hill Road Douglassville, Pennsylvania 19518
Re: K180437
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: April 6, 2018 Received: April 9, 2018
Dear Mr. Guthner:
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180437
Device Name Hexanium® TLIF
Indications for Use (Describe)
The Hexanium® TLIF (Transformational 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submitter | SpineVision SAS
10 rue de la Renaissance
Batiment E
92160 Antony - FRANCE |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Contact | Anaëlla Gallego
QA and RA Manager
Tel: +33 1 53 33 25 25
Fax: +33 1 72 69 00 30
EMAIL: a.gallego@spinevision.com |
| Correspondent
Contact | Donald W. Guthner
ORGENIX LLC
111 Hill Road
Douglassville, PA 19518
USA
Tel. +1 646-460-2984
Fax. +1 484-363-5879
Email: dg@orgenix.com |
| Device Name | Hexanium® TLIF |
| Class | Class II |
| Product Code | MAX: Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification | 888.3080: Intervertebral body fusion device |
| Device Panel | Orthopedic |
| Primary Predicate
device | K153783 – SpaceVision® Interbody Fusion Cages, SpineVision SAS |
| Device Description | The Hexanium® TLIF device 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 heights of 7mm to 16mm in 1mm
increments in a Small footprint (28mm X 9mm) or a Medium footprint
(32mm X 10.5mm). 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 Hexanium® TLIF device conforms to the Class II Special
Controls Guidance Document: Intervertebral Body Fusion
Device Document issued on June 12, 2007. |
| | Mechanical testing includes static compression, dynamic compression,
static compression shear and dynamic compression shear performed
according to ASTM F2077-14, subsidence testing performed according
to ASTM 2267-04 and expulsion testing. |
| | Mechanical testing was performed in a side-by-side comparison to the
predicate device. |
| | Results demonstrate comparable mechanical properties to the predicate
device. |
| | Bacterial Endotoxins Test was performed in accordance to 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 SpaceVision Interbody Fusion Cages in terms of
intended use, design, mechanical properties and function. |
| Conclusion | The Hexanium® TLIF is substantially equivalent to the
predicate device. |
| Date | 2018-05-03 |
510K SUMMARY
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