(240 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of a spinal fixation system, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is described as a "posterior fixation system for stabilizing the thoracic, lumbar and sacral spine" intended "as an adjunct to fusion" for various spinal conditions, indicating it directly treats or alleviates a disease or injury.
No
This device is a surgical implant system designed to provide immobilization and stabilization of spinal segments, acting as an adjunct to fusion. It is used in the treatment of various spinal conditions, not for diagnosing them.
No
The device description clearly outlines physical components such as pedicle screws, iliac screws, revision screws, hooks, rods, and instrumentation, all made from specific materials like titanium alloy and cobalt chrome alloy. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the VERTICALE® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the immobilization and fusion of spinal segments in patients. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a posterior fixation system consisting of implants (screws, hooks, rods) and instruments for surgical implantation. These are physical devices used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The VERTICALE® System does not interact with or analyze such specimens.
- Performance Studies: The performance studies focus on mechanical testing of the implants and instruments, biocompatibility, and validation of processes like cleaning and sterilization. These are typical evaluations for surgical implants, not IVDs which would involve analytical and clinical performance studies related to specimen analysis.
Therefore, the VERTICALE® System is a surgical implant system, not an IVD.
N/A
Intended Use / Indications for Use
The VERTICALE® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VERTICALE® MIS System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VERTICALE® MIS metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The subject device is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP
Device Description
The VERTICALE® System is a posterior fixation system for stabilizing the thoracic, lumbar and sacral spine. The VERTICALE® System is a modular, versatile fixation system consisting of pedicle screws, iliac screws, revision screws, hooks and rods for the fusion of treated spinal segments.
The pedicle screws are available in a range of sizes, and in solid, cannulated and fenestrated designs, which when used in combination with the rods, can be used for a range of indications. The pedicle screws and hooks are manufactured from titanium alloy and the rods, from titanium alloy or cobalt chrome alloy.
The VERTICALE® System comprises modular ergonomically designed, bi-functional two-in-one (2 in 1) instruments with modular handle options. The VERTICALE® System also offers a set of minimal invasive instrumentation (MIS) to facilitate minimally invasive implantation of the components.
The VERTICALE® System is color coded by diameter for ease of identification.
The VERTICALE® implants are manufactured from Ti6Al4V ELI conforming to ASTM F136 and CoCrMo conforming to ASTM F1537. The VERTICALE® System specific instruments are manufactured from materials conforming to ISO 16061 and ASTM F899.
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.q., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients (specifically for adolescent idiopathic scoliosis)
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)
Non-Clinical Performance Data: As part of demonstrating safety and effectiveness of VERTICALE® System and in showing substantial equivalence to the predicate devices, Silony Medical GmbH completed a number of non-clinical performance tests. The VERTICALE® System meets all the requirements for overall design, sterilization, biocompatibility, and performance testing results confirming that the design output meets the design inputs and specifications for the device. The VERTICALE® System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Mechanical testing Tested in accordance with ASTM F1717-15 for static compression . bending, static tension bending, static torsion and fatigue with acceptable results.
- . Mechanical testing - Tested in accordance with ASTM F1798-13 for static axial slipping, polyaxial slipping, head splay and fatigue with acceptable results.
- . Biocompatibility - Biological evaluation was performed according to 10993-1 on known materials supporting that no toxic substances or materials are used; materials used for the subject device are materials all used in marketed implant devices.
- o Validation activities have been successfully conducted for cleaning and sterilization, packaging, shelf life and transport.
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. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
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 the FDA logo, which 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.
January 10, 2018
Silony Medical GmbH % Ms. Indraj Bamrah Senior Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K171421
Trade/Device Name: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: December 6, 2017 Received: December 8, 2017
Dear Ms. Bamrah:
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);
1
Page 2 - Ms. Indraj Bamrah
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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171421
Device Name
VERTICALE® Posterior Spinal Fixation System / VERTICALE® System
Indications for Use (Describe)
The VERTICALE® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VERTICALE® MIS System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VERTICALE® MIS metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The subject device is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
VERTICALE® POSTERIOR SPINAL FIXATION SYSTEM K171421
1. Submission Sponsor
| Silony Medical GmbH | |
|---|---|
| Leinfelder Straße 60 | |
| Leinfelden-Echterdingen | |
| 70771 | |
| Germany | |
| Contact: | Bircan Tasdelen |
| Title: | Head of Quality Management and Regulatory Affairs |
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Indraj Bamrah Title: Senior Regulatory Consultant
-
- Date Prepared
December 06, 2017
- Date Prepared
4. Device Identification
Trade/Proprietary Name: VERTICALE® Posterior Spinal Fixation System / VERTICALE® System
| Common/Usual Name: | Pedicle Screw Spinal System | |
|---|---|---|
| Classification Name: | Pedicle Screw Spinal System | |
| Regulation Number: | 21 CFR 888.3070 Thoracolumbosacral Pedicle Screw System | |
| Product Code: | NKB, KWP | |
| Device Class: | Class II | |
| Classification Panel: | Orthopedic |
4
5. Legally Marketed Predicate Device(s)
Primary Predicate
K131802. Expedium Spine System,VIPER and VIPER 2 Systems Medos International Sárl.
Additional Predicate
K092287, NuVasive SpheRx II (Armada) - Pedicle Screw System, NuVasive Inc.
6. Indication for Use Statement
The VERTICALE® System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VERTICALE® MIS System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VERTICALE® and VERTICALE® MIS metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic sooliosis. The subject device is intended to be used with autograff and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
7. Device Description
The VERTICALE® System is a posterior fixation system for stabilizing the thoracic, lumbar and sacral spine. The VERTICALE® System is a modular, versatile fixation system consisting of pedicle screws, iliac screws, revision screws, hooks and rods for the fusion of treated spinal segments.
The pedicle screws are available in a range of sizes, and in solid, cannulated and fenestrated designs, which when used in combination with the rods, can be used for a range of indications. The pedicle screws and hooks are manufactured from titanium alloy and the rods, from titanium alloy or cobalt chrome alloy.
The VERTICALE® System comprises modular ergonomically designed, bi-functional two-in-one (2 in 1) instruments with modular handle options. The VERTICALE® System also offers a set of
5
minimal invasive instrumentation (MIS) to facilitate minimally invasive implantation of the components.
The VERTICALE® System is color coded by diameter for ease of identification.
The VERTICALE® implants are manufactured from Ti6Al4V ELI conforming to ASTM F136 and CoCrMo conforming to ASTM F1537. The VERTICALE® System specific instruments are manufactured from materials conforming to ISO 16061 and ASTM F899.
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.q., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
8. Substantial Equivalence Discussion
The VERTICALE® System has been shown to be substantially equivalent to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing.
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of VERTICALE® System and in showing substantial equivalence to the predicate devices, Silony Medical GmbH completed a number of non-clinical performance tests. The VERTICALE® System meets all the requirements for overall design, sterilization, biocompatibility, and performance testing results confirming that the design output meets the design inputs and specifications for the device.
The VERTICALE® System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Mechanical testing Tested in accordance with ASTM F1717-15 for static compression . bending, static tension bending, static torsion and fatigue with acceptable results.
- . Mechanical testing - Tested in accordance with ASTM F1798-13 for static axial slipping, polyaxial slipping, head splay and fatigue with acceptable results.
- . Biocompatibility - Biological evaluation was performed according to 10993-1 on known materials supporting that no toxic substances or materials are used; materials used for the subject device are materials all used in marketed implant devices.
- o Validation activities have been successfully conducted for cleaning and sterilization, packaging, shelf life and transport.
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. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of
6
the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device; or the device has the same intended use and different technological characteristics, but it can be demonstrated that the device is substantially equivalent to the predicate device and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate devices.
The VERTICALE® System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.