(253 days)
No
The provided 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The focus is on the physical components, materials, and mechanical performance testing.
Yes
The device is described as "intended to provide immobilization of spinal segments as an adjunct to fusion" and "for immobilization and stabilization of the spinal segments." This function clearly indicates a therapeutic purpose.
No
The device is a surgical fixation system intended to immobilize and stabilize spinal segments, not to diagnose medical conditions.
No
The device description clearly states it is a posterior double rod fixation system consisting of polyaxial screws, rods, plates, connectors, and instrumentation, all made from titanium alloy. This describes physical hardware implants and surgical tools, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The VERTICALE Cervical System is a surgical implant designed to provide mechanical support and stabilization to the spine. It is physically implanted into the patient's body.
- Intended Use: The intended use is to immobilize spinal segments as an adjunct to fusion for various spinal instabilities and conditions. This is a structural and mechanical function, not a diagnostic test performed on a sample.
The device description and intended use clearly indicate that this is a surgical implant used for structural support and stabilization within the body, not a diagnostic tool used on samples outside the body.
N/A
Intended Use / Indications for Use
The VERTICALE Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction (occiput-C2), the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- traumatic spinal fractures and /or traumatic dislocations
- instability or deformity
- failed previous fusions (e.g. pseudoarthrosis)
- tumors involving the cervical/thoracic spine
- degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- degenerative disease of the facets with instability
Product codes
NKG, KWP
Device Description
The VERTICALE Cervical System is a posterior double rod fixation system for immobilization and stabilization of the spinal seqments of the craniocervical junction (occiput-C2), cervical spine (C1-C7), and thoracic spine (T1-T3).
The system may only be used in the field of human medicine and consists of polyaxial screws, favored anqle polyaxial (FA) screws, rods, occiput plates, connectors and the related instrumentation.
The VERTICALE Cervical System will be used in patients with occiput cervical and upper cervical spine instabilities.
The implants of the VERTICALE Cervical System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3. They are delivered in a sterile condition and can be used without any further preparations. The implants are packaged in accordance with EN ISO 11607 Part 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. They are intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction (occiput-C2), the cervical spine (C1 to C7) and the thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
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: Silony Medical completed a number of non-clinical performance tests. The VERTICALE Cervical System 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 VERTICALE Cervical System passed all the testing in accordance with internal requirements, national and international standards shown below to support substantial equivalence of the subject device:
- Mechanical performance according to:
- ASTM F1717-18: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (static and dynamic compression bending and static and dynamic torsion)
- ASTM F2706-18: Standard Test Methods for Occipital-Cervical and Occipital-Cervical Thoracic Spinal Implant Constructs in a Vertebrectomy Model (static and dynamic compression bending and static and dynamic torsion)
- ASTM F1798-13: Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants (static axial grip and static and dynamic flexion-extension)
- Biocompatibility according ISO 10993-1
- Cleaning and Sterilization testing according ISO 11137
- Shelf Life testing for 10 years
- Storage and Transport testing
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 7, 2020
Silony Medical GmbH Melanie Lubjuhn Team Leader Regulatory Affairs Leinfelder StraBe 60 Leinfelden-Echterdingen, 70771 De
Re: K192013
Trade/Device Name: VERTICALE® Cervical System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: March 11, 2020 Received: March 13, 2020
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 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
1
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 medical devices and radiation-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.
Colin O'Neill, M.B.E. Acting 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
2
Indications for Use
510(k) Number (if known) K192013
Device Name VERTICALE® Cervical System
Indications for Use (Describe)
The VERTICALE Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction (occiput-C2), the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
-
traumatic spinal fractures and /or traumatic dislocations
-
instability or deformity
-
failed previous fusions (e.g. pseudoarthrosis)
-
tumors involving the cervical/thoracic spine
-
degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and
-
degenerative disease of the facets with instability
| 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
VERTICALE® Cervical System
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
26th July 2019
4. Device Identification
| Trade/Proprietary Name: | VERTICALE® Cervical System |
|---|---|
| Common/Usual Name: | Posterior Cervical Screw System |
| Regulation Number: | 888.3075 |
| Product Code: | NKG, KWP |
| Device Class: | II |
| Classification Panel: | Orthopedic |
5. Legally Marketed Primary Predicate Device
Mountaineer OCT Spinal System; DePuy Spine, Inc.; K151885
4
6. Device Description
The VERTICALE Cervical System is a posterior double rod fixation system for immobilization and stabilization of the spinal seqments of the craniocervical junction (occiput-C2), cervical spine (C1-C7), and thoracic spine (T1-T3).
The system may only be used in the field of human medicine and consists of polyaxial screws, favored anqle polyaxial (FA) screws, rods, occiput plates, connectors and the related instrumentation.
The VERTICALE Cervical System will be used in patients with occiput cervical and upper cervical spine instabilities.
The implants of the VERTICALE Cervical System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3. They are delivered in a sterile condition and can be used without any further preparations. The implants are packaged in accordance with EN ISO 11607 Part 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. They are intended for single use.
7. Indication for Use Statement
The VERTICALE Cervical System is intended to provide immobilization and stabilization of spinal seqments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction (occiput-C2), the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- traumatic spinal fractures and /or traumatic dislocations
- instability or deformity
- failed previous fusions (e.g. pseudoarthrosis)
- tumors involving the cervical/thoracic spine
- degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- degenerative disease of the facets with instability
8. Substantial Equivalence Discussion
The VERTICALE Cervical system 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 the VERTICALE Cervical System 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 VERTICALE Cervical System 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.
5
The VERTICALE Cervical System passed all the testing in accordance with internal requirements, national and international standards shown below to support substantial equivalence of the subject device:
- Mechanical performance according to: -
- ASTM F1717-18: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy o Model (static and dynamic compression bending and static and dynamic torsion)
- ASTM F2706-18: Standard Test Methods for Occipital-Cervical and Occipital-Cervical o Thoracic Spinal Implant Constructs in a Vertebrectomy Model (static and dynamic compression bending and static and dynamic torsion)
- ASTM F1798-13: Standard Test Method for Evaluating the Static and Fatigue Properties of o Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants (static axial grip and static and dynamic flexion-extension)
- -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 VERTICALE Cervical System is determined to be substantially equivalent to the referenced predicate device.