(56 days)
Not Found
No
The summary describes a physical implant (interbody cage) and its mechanical properties, with no mention of software, algorithms, or data processing that would typically involve AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes.
The device is used to treat Degenerative Disc Disease (DDD) through intervertebral body fusion, which is a therapeutic intervention aimed at alleviating pain and restoring function.
No
The device description clearly states it is an "intervertebral body fusion device" and an "interbody cage," which is an implant used in surgery, not a tool for diagnosis. Its intended use is to treat Degenerative Disc Disease, not to diagnose it.
No
The device description clearly states it is a titanium alloy interbody cage manufactured via additive manufacturing, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Hexanium® PLIF system is an implantable medical device used in surgery to fuse vertebrae in the lumbar spine. It is a physical object implanted into the body, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing.
Therefore, based on the provided information, the Hexanium® PLIF system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hexanium® PLIF (Posterior 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 PLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via the posterior approach. Hexanium PLIF 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® PLIF (Posterior Lumbar Interbody Fusion) 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 cage as well as providing lateral and vertical bone graft windows in the body of the cage.
Hexanium® PLIF cages are available in heights of 7-16 mm (in 1 mm increments), width of 9 mm, lengths of 22 and 25 mm, and lordosis angles of 0°, 5°, and 8°.
Hexanium® PLIF cages are provided sterile and supplied with a set of non-sterile surgical instruments.
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)
Hexanium® PLIF cages conform to the FDA guidance “Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" dated June 12, 2007.
Mechanical testing includes static compression, static compression-shear, static torsion, dynamic compression, dynamic compression-shear, and dynamic torsion performed according to ASTM F2077, subsidence testing performed according to ASTM F2267, and expulsion testing performed according to draft ASTM F-04.25.02.02.
The Hexanium® PLIF cages meet the same pre-determined functional and performance requirements and external standard requirements as the predicate devices and do not raise any new questions of safety or effectiveness.
Bacterial Endotoxins Test was performed in accordance with 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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December 16, 2022
SpineVision, S.A.S. Ms. Nancy Lincé President & CEO Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K223251
Trade/Device Name: Hexanium® PLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 20, 2022 Received: October 21, 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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Indications for Use
510(k) Number (if known) K223251
Device Name Hexanium® PLIF
Indications for Use (Describe)
The Hexanium® PLIF (Posterior 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 at the involved level(s ). Patients should have received at least 6 months of non-operative treatment with Hexanium PLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via the posterior approach. Hexanium PLIF 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 | October 20, 2022 |
|---|---|
| Submitter | SpineVision, S.A.S. |
| 10 rue de la Renaissance | |
| Bâtiment E | |
| 92160 Antony | |
| FRANCE | |
| Submitter Contact | Quang Tran |
| Director, Quality Assurance & Regulatory Affairs | |
| Phone: +33 1 53 33 25 25 | |
| Email: q.tran@spinevision.com | |
| Correspondent | |
| Contact | Nancy Lincé |
| Lincé Consulting, LLC | |
| U.S. Agent | |
| Regulatory Affairs Consultant | |
| Phone: (650) 759-6186 | |
| Email: nlince@linceconsulting.com | |
| Device Name | Hexanium® PLIF |
| Class | Class II |
| Product Code | MAX: Intervertebral Fusion Device with Bone Graft, Lumbar |
| CFR Section | 21 CFR§888.3080: Intervertebral body fusion device |
| Device Panel | Orthopedic |
| Primary Predicate | K210359 SpineVision SAS Hexanium® TLIF |
| Additional Predicate | K153783 SpineVision SpaceVision® PLIF |
| Device Description | The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) 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 cage as well as providing lateral and | |
| vertical bone graft windows in the body of the cage. | |
| Hexanium® PLIF cages are available in heights of 7-16 mm (in 1 mm | |
| increments), width of 9 mm, lengths of 22 and 25 mm, and lordosis angles | |
| of 0°, 5°, and 8°. | |
| Hexanium® PLIF cages are provided sterile and supplied with a set of non- | |
| sterile surgical instruments. | |
| Indications for Use | The Hexanium® PLIF (Posterior 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 PLIF system. This device has to be filled with | |
| autogenous bone graft material. This device is implanted via the posterior | |
| approach. Hexanium PLIF 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 | Hexanium® PLIF cages conform to the FDA guidance “Guidance for |
| Industry and FDA Staff – Class II Special Controls Guidance Document: | |
| Intervertebral Body Fusion Device" dated June 12, 2007. | |
| Mechanical testing includes static compression, static compression-shear, | |
| static torsion, dynamic compression, dynamic compression-shear, and | |
| dynamic torsion performed according to ASTM F2077, subsidence testing | |
| performed according to ASTM F2267, and expulsion testing performed | |
| according to draft ASTM F-04.25.02.02. | |
| The Hexanium® PLIF cages meet the same pre-determined functional and | |
| performance requirements and external standard requirements as the | |
| predicate devices and do not raise any new questions of safety or | |
| effectiveness. | |
| 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® PLIF is substantially equivalent to the predicate device in |
| terms of intended use, indications for use, design, function, technology, | |
| materials, safety, and performance as well as procedural steps, surgical | |
| instrumentation, and product labeling. | |
| Conclusion | The Hexanium® PLIF is substantially equivalent to the predicate device. |
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