(122 days)
No
The device description and performance studies focus on the mechanical properties, biocompatibility, and sterilization of a spinal implant, with no mention of AI or ML technology.
Yes.
Explanation: The device is an implant for spinal fusion, indicated for treating symptomatic disc degeneration and degenerative disc disease, which are medical conditions, and aims to restore physiological lordosis, correct deformities, and remedy instabilities, which are therapeutic effects.
No
Explanation: The FAVO S-TLIF Cage is an implant designed for intervertebral body fusion to treat degenerative disc disease and related conditions. It is a therapy device that facilitates fusion and provides biomechanical support, not a diagnostic tool for identifying diseases or conditions.
No
The device description clearly states it is an implantable cage made of titanium alloy, which is a physical hardware component. The summary also details mechanical performance testing and sterilization, further indicating a hardware device.
Based on the provided text, the FAVO S-TLIF Cage 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, tissue) to provide information for diagnosis, monitoring, or screening.
- FAVO S-TLIF Cage Function: The FAVO S-TLIF Cage is a surgical implant designed to be placed within the human body to provide structural support and facilitate bone fusion in the spine. It does not analyze biological samples.
The description clearly states its purpose is for intervertebral body fusion and stabilization, which are surgical procedures, not diagnostic tests performed on samples outside the body.
N/A
Intended Use / Indications for Use
The FAVO S-TLIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.
The FAVO S-TLIF Cage is intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
The FAVO S-TLIF Cage is intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The FAVO S-TLIF Cage can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Product codes
MAX, PHM
Device Description
The FAVO S-TLIF (straight transforaminal lumbar interbody fusion) Cage is an implant for primary stabilization and restoration of physiological lordosis in the lumbar and thoracic spine. The cage is designed for transforaminal approaches.
The aim is to eliminate discogenic back pain, correct deformities, remedy instabilities, restore intervertebral height, restore physiological lordosis, and provide biomechanical support for bone fusion in the disc space.
The system is designed for use with autogenous bone graft to facilitate fusion and must be used with additional stabilization. For posterior lumbar stabilization, Silony Medical recommends the use of a posterior spinal fixator (e.g., the VERTICALE system). The devices are to be used in patients who have had at least six months of non-operative treatment. The FAVO S-TLIF is manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and ASTM F3001.
The FAVO S-TLIF implant is delivered in a sterile condition and can be used without any further preparations. The cages are packaged in accordance with EN ISO 11607 Party 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy.
Implants delivered by the manufacturer in a sterile condition may not be sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), lumbar spine, from L1 to 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
Non-clinical performance tests for overall design, sterilization, biocompatibility, and performance testing.
Testing included:
- Mechanical performance according to ASTM F2077 (static axial compression, static compressive shear, dynamic axial compression and dynamic compressive shear)
- ASTM F2267 for Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- Static expulsion behavior
- Biocompatibility according to ISO 10993-1
- Cleaning and Sterilization Testing according to ISO 11137
- Shelf Life Testing for 10 years
- Storage and Transport Testing
No human clinical testing was required as the indications for use are equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K180963, ROCCIA® TLIF Cage, Silony Medical GmbH
Reference Device(s)
K172888; EIT Cellular Titanium TLIF Cage, EIT Emerging Implant Technologies GmbH
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.
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Silony Medical GmbH Melanie Lubjuhn Team Leader Regulatory Affairs Leinfelder StraBe 60 70771 Leinfelden-Echterdingen Germany
Re: K190680
Trade/Device Name: Favo® S-TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: May 20, 2019 Received: May 23, 2019
Dear Melanie Lubjuhn:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
July 18, 2019
1
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 (OS) 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,
for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190680
Device Name FAVO® S-TLIF
Indications for Use (Describe)
The FAVO S-TLIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.
The FAVO S-TLIF Cage is intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectorny for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy with or without axial pain).
The FAVO S-TLIF Cage is intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The FAVO S-TLIF Cage can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
| 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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510(k) Summary
FAVO® S-TLIF
K190680
1. Submission Sponsor
Silony Medical GmbH Leinfelder Straße 60 70771 Leinfelden-Echterdingen GERMANY Phone Number: +49 711 78 25 25 67 Contact: Melanie LUBJUHN Title: Team Leader Regulatory Affairs
2. Submission Correspondent
Silony Medical GmbH Leinfelder Straße 60 70771 Leinfelden-Echterdingen GERMANY Contact: Melanie LUBJUHN Office Phone: +49 711 78 25 25 67 Email: MLubjuhn@silony-medical.com
3. Date Prepared
14th March 2019
4. Device Identification
| Trade/Proprietary Name: | FAVO S-TLIF |
|---|---|
| Common/Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Lumbar |
| Intervertebral Body Fusion Device with Bone Graft, Thoracic | |
| Regulation Number: | 888.3080 |
| Product Code: | MAX, PHM |
| Device Class: | II |
| Classification Panel: | Orthopedic |
5. Legally Marketed Predicate Device
Primary Predicate Device K180963, ROCCIA® TLIF Cage, Silony Medical GmbH
Additional Predicate Device K172888; EIT Cellular Titanium TLIF Cage, EIT Emerging Implant Technologies GmbH
4
6. Device Description
The FAVO S-TLIF (straight transforaminal lumbar interbody fusion) Cage is an implant for primary stabilization and restoration of physiological lordosis in the lumbar and thoracic spine. The cage is designed for transforaminal approaches.
The aim is to eliminate discogenic back pain, correct deformities, remedy instabilities, restore intervertebral height, restore physiological lordosis, and provide biomechanical support for bone fusion in the disc space.
The system is designed for use with autogenous bone graft to facilitate fusion and must be used with additional stabilization. For posterior lumbar stabilization, Silony Medical recommends the use of a posterior spinal fixator (e.g., the VERTICALE system). The devices are to be used in patients who have had at least six months of non-operative treatment. The FAVO S-TLIF is manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and ASTM F3001.
The FAVO S-TLIF implant is delivered in a sterile condition and can be used without any further preparations. The cages are packaged in accordance with EN ISO 11607 Party 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy.
Implants delivered by the manufacturer in a sterile condition may not be sterilized.
7. Indication for Use Statement
The FAVO S-TLIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.
The FAVO S-TLIF Cage is intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
The FAVO S-TLIF Cage is intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The FAVO S-TLIF Cage can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
8. Substantial Equivalence Discussion
The FAVO S-TLIF has shown to be substantial equivalent to the predicate device mentioned in chapter 5 of this section with respect to indications for use, principles of operations, technological characteristics, materials, and performance testing.
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of FAVO S-TLIF and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Silony Medical completed a number of non-clinical performance tests. The FAVO S-TLIF meets all the requirements for overall design, sterilization, biocompatibility, and performance testing results confirming that the design output meets the design inputs specifications for the device.
The FAVO S-TLIF passed all the testing in accordance with internal requirements, national and international standards shown below to support substantial equivalence of the subject device:
5
- Mechanical performance according -
- ASTM F2077 for Test Methods for Intervertebral Body Fusion Devices (static axial o compression, static compressive share, dynamic axial compression and dynamic compressive share)
- O ASTM F2267 for Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- -Static expulsion behavior
- -Biocompatibility according ISO 10993-1
- -Cleaning and Sterilization Testing according ISO 11137
- -Shelf Life Testing for 10 years
- -Storage and Transport Testing
10.Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11.Statement of Substantial Equivalence
The FAVO S-TLIF is determined to be substantially equivalent to the referenced predicate device(s).