(256 days)
Not Found
No
The device description and intended use focus on the mechanical components and surgical application of a spinal fixation system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various acute and chronic instabilities and diseases of the craniocervical junction, cervical spine, and thoracic spine. It is also used to restore the integrity of the spinal column for a limited time in patients with advanced stage tumors. These indications clearly describe a medical purpose to treat or mitigate a disease or condition, which aligns with the definition of a therapeutic device.
No
This device is a spinal fixation system, intended to provide immobilization and support as an adjunct to fusion for instabilities and deformities of the spine. It is an implantable device used for treatment, not for diagnosing conditions.
No
The device description clearly outlines multiple physical components made of metal alloys, such as screws, rods, and plates, which are hardware.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the COSY Cervicothoracic Occipital Rod-Screw System is a "multiple component, posterior spinal fixations system" consisting of implants like screws, rods, plates, and hooks. These are physical devices implanted into the body.
- Intended Use: The intended use is to "provide immobilization of spinal segments as an adjunct to fusion" for various spinal instabilities and conditions. This involves surgical implantation and mechanical support, not testing of biological samples.
The device is a surgical implant used to stabilize the spine, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The COSY Cervicothoracic Occipital Rod-Screw 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, the cervical spine (C1-C7), and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instabilities or deformity; failed previous fe.g., pseudoarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radioulopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The COSY cervicothoracic occipital rod-screw system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage turnors involving the cervical spine in whom life expectancy is of limited duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the COSY Cervicothoracic Occipital Rod-Screw System may be connected to the components of the DIPLOMAT System or MONOPOLY System using the rod-to-rod connectors or transition rods.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The COSY Cervicothoracic Occipital Rod-Screw is a multiple component, posterior spinal fixations system which consists of solid screws, cannulated screws, standard tulips, angulated tulips, curved rods, straight rods, hybrid rods, parallel connectors, inline connectors, occipital plates, occipital bone screws, hooks, and offset connectors.
All implants, except of variations of the rods, are available in Ti-6AL-4V ELI per ASTM F136. Rods are available in Ti-6AL-4V ELI per ASTM F136 or Co-Cr28-Mo6 per ASTM F1537.
The pedicle screws consist of a tulip and a pedicle screw shaft. The shaft has a prominent thread, to provide anchorage of the screw in the pedicle section of the vertebrae. Each tulip is securely attached to the rod via a set screw.
The shafts of the pedicle screws are provided in different lengths, diameters, fully or partially threaded, and with a symmetric anqulation to provided adaptability to the patient's anatomy. The rods can be shortened on site by the surgeon.
The occipital plate is available with four or five holes and areas to be bent for better fixation to the occipital part of the skull. The plate is fixed via bone screws and as two gliding tulips to provided anchoring of the rod. The gliding tulips are constructed similar to the tulips of the pedicle screws in the area of the rod- set screw -tulip intersection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1-C7), and the thoracic spine from 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)
Mechanical Testing:
- Dynamic Compression-Bending per ASTM F2706-18
- Dynamic Axial Torsion per ASTM F2706-18
- Static Axial Gripping per ASTM F1798-13
- Static Compression-Bending per ASTM F2706-18
- Static Torsion per ASTM F2706-18
- Dynamic Compression-Bending per ASTM F1717-18
- Dynamic Flexion/Extension Bending per ASTM F1798-13
- Static Compression-Bending per ASTM F1717-18
- Statix Flexion/ Extension Bending per ASTM F1798-13
- Static Axial Torsion per ASTM F1717-18
Key results: Through assessment of technological characteristics, indications for use, and performance data, it can be concluded that the subject COSY Cervicothoracic Occipital Rod-Screw System is substantially equivalent to the predicate 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
§ 888.3075 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.
0
November 18, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
SIGNUS Medizintechnik GmbH Mr. Holger Noss Head of Regulatory & Quality Industriestrasse 2 Alzenau, Bavaria 63755 Germany
Re: K220658
Trade/Device Name: COSY Cervicothoracic Occipital Rod-Screw System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: October 24, 2022 Received: October 24, 2022
Dear Mr. Noss:
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 (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 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 -S
Colin O'Neill, M.B.E. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K220658
Device Name
COSY Cervicothoracic Occipital Rod-Screw System
Indications for Use (Describe)
The COSY Cervicothoracic Occipital Rod-Screw 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, the cervical spine (C1-C7), and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instabilities or deformity; failed previous fe.g., pseudoarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radioulopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The COSY cervicothoracic occipital rod-screw system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage turnors involving the cervical spine in whom life expectancy is of limited duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the COSY Cervicothoracic Occipital Rod-Screw System may be connected to the components of the DIPLOMAT System or MONOPOLY System using the rod-to-rod connectors or transition rods.
| 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
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR 807.92, the following summary of information is provided.
Date of Perparation
February 22, 2022
Applicant
| Company: | SIGNUS Medizintechnik GmbH |
|---|---|
| Street: | Industriestrasse 2 |
| Postcode, City: | 63755 Alzenau |
| Country: | Germany |
Contact Person
| Name: | Mr. Holger Noss |
|---|---|
| Position: | Head of Quality Management |
| Tel: | 0049 6023 9166 212 |
| E-Mail: | h.noss@signus.com |
Device Name
| Trade name: | COSY Cervicothoracic Occipital Rod-Screw System |
|---|---|
| Regulation Description: | Posterior Cervical Screw System |
| Regulation Number: | 888.3075 |
| Product Code: | NKG, KWP |
| Classification: | Class II |
| Panel: | Orthopedic |
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| Trade Name | Clearance | Claim of Equivalence for: | 510(k) holder |
|---|---|---|---|
| Gibralt Spine System | K160197, cleared | ||
| on June 28, 2016 | Predicate Device | EXACTECH Inc. | |
| (spinal assets of | |||
| EXACTECHE | |||
| were acquired | |||
| by ChoiceSpine | |||
| in 2017) |
Indications for Use
The COSY Cervicothoracic Occipital Rod-Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7), and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instabilities or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical 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.
The COSY cervicothoracic occipital rod-screw system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of limited duration to permit achievement of fusion. In order to achieve additional levels of fixation, the COSY Cervicothoracic Occipital Rod-Screw System may be connected to the components of the DIPLOMAT System or MONOPOLY System using the rod-to-rod connectors or transition rods.
Device Description
The COSY Cervicothoracic Occipital Rod-Screw is a multiple component, posterior spinal fixations system which consists of solid screws, cannulated screws, standard tulips, angulated tulips, curved rods, straight rods, hybrid rods, parallel connectors, inline connectors, occipital plates, occipital bone screws, hooks, and offset connectors.
5
All implants, except of variations of the rods, are available in Ti-6AL-4V ELI per ASTM F136. Rods are available in Ti-6AL-4V ELI per ASTM F136 or Co-Cr28-Mo6 per ASTM F1537.
The pedicle screws consist of a tulip and a pedicle screw shaft. The shaft has a prominent thread, to provide anchorage of the screw in the pedicle section of the vertebrae. Each tulip is securely attached to the rod via a set screw.
The shafts of the pedicle screws are provided in different lengths, diameters, fully or partially threaded, and with a symmetric anqulation to provided adaptability to the patient's anatomy. The rods can be shortened on site by the surgeon.
The occipital plate is available with four or five holes and areas to be bent for better fixation to the occipital part of the skull. The plate is fixed via bone screws and as two gliding tulips to provided anchoring of the rod. The gliding tulips are constructed similar to the tulips of the pedicle screws in the area of the rod- set screw -tulip intersection.
Comparison of Technological Characteristics with the Predicate Device
The subject device has the following in common with the primary predicate device: indications for use, intended use, general design characteristics, and materials of construction. Any differences do not result in new questions of safety or effectiveness.
Mechanical Testing
Testing was conducted according to:
| • Dynamic Compression-Bending | per ASTM F2706-18 |
|---|---|
| • Dynamic Axial Torsion | per ASTM F2706-18 |
| • Static Axial Gripping | per ASTM F1798-13 |
| • Static Compression-Bending | per ASTM F2706-18 |
| • Static Torsion | per ASTM F2706-18 |
| • Dynamic Compression-Bending | per ASTM F1717-18 |
| • Dynamic Flexion/Extension Bending | per ASTM F1798-13 |
| • Static Compression-Bending | per ASTM F1717-18 |
| • Statix Flexion/ Extension Bending | per ASTM F1798-13 |
| • Static Axial Torsion | per ASTM F1717-18 |
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Conclusion
Through assessment of technological characteristics, indications for use, and performance data, it can be concluded that the subject COSY Cervicothoracic Occipital Rod-Screw System is substantially equivalent to the predicate device.