(63 days)
No
The device description and intended use describe a mechanical spinal fixation system consisting of rods, screws, hooks, and connectors. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes.
The device is intended to immobilize spinal segments and restore the integrity of the spinal column for various medical conditions, indicating a therapeutic purpose.
No
Explanation: The VERTEX® Reconstruction System is described as a posterior system of rods, screws, hooks, and connecting components intended for immobilization of spinal segments as an adjunct to fusion. This indicates it is a surgical implant device used for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of "a variety of shapes and sizes of rods, screws, hooks, and connecting components," which are physical hardware components used in spinal surgery. There is no mention of software being the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to provide immobilization and stability to the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like rods, screws, hooks, and cables, which are typical of surgical implants.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing and clinical outcomes related to the device's structural integrity and effectiveness in spinal fusion and stabilization. This is consistent with a surgical implant.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VERTEX® Reconstruction System does not fit this description.
N/A
Intended Use / Indications for Use
The VERTEX® Reconstruction 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 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and 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 instability. The VERTEX® Reconstruction 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 advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
Product codes
NKG, KWP
Device Description
The subject VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, screws, hooks, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® Cable may be used with this system at the surgeon's discretion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, cervical spine (C1 to C7), 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
Retrospective clinical data provided in support of this application along with the published clinical outcomes of additional patients treated with the VERTEX® device for the indications sought, demonstrates the subject device is substantially equivalent to the AXIS® Fixation System when used to treat the aforementioned indications. Mechanical testing was also provided to support a substantial equivalence determination of the subject VERTEX® Reconstruction System. Testing consisted of the following:
Unblocked Compression Fatigue and Static Compression Testing of Multi-Axial Screws (MAS) -ASTM F1717
Semi-Blocked Torsion Fatigue and Static Torsion Testing of Occipital Cervical Module with MAS – ASTM F2706
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2015
Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132
Re: K143471
Trade/Device Name: VERTEX® Reconstruction System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: December 1, 2014 Received: December 5, 2014
Dear Mr. Grant:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Lee Grant
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
VincentJ. Devlin -S
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143471
Device Name VERTEX® Reconstruction System
Indications for Use (Describe)
The VERTEX® Reconstruction 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 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and 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 instability. The VERTEX® Reconstruction 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 advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| | VERTEX® Reconstruction System
510(k) Summary – K143471
November 2014 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Medtronic Sofamor Danek USA
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 |
| Contact: | Lee Grant
Distinguished Regulatory Affairs Advisor |
| Proprietary Trade Name: | VERTEX® Reconstruction System |
| Regulatory Identification/
Classification: | Orthosis, Cervical Pedicle Screw Spinal Fixation
Product Code: NKG
Unclassified, Pre-Amendment
Spinal Interlaminar Fixation Orthosis
Regulation Number: 888.3050
Product Code: KWP
Class II |
Description: The subject VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, screws, hooks, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® Cable may be used with this system at the surgeon's discretion.
Indications for Use: The VERTEX® Reconstruction 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 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and 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 VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited
4
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.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
Summary of the Technological Characteristics: The subject VERTEX® Reconstruction System has a similar fundamental scientific technology as the predicate AXIS® Fixation System (primary predicate) and is identical to the VERTEX® Reconstruction System (reference device). The subject device utilizes equivalent surgical approaches, implant materials, surgical instruments and sterilization methods as the predicate AXIS® device.
Identification of Legally Marketed Devices: The subject VERTEX® Reconstruction System is substantially equivalent to the predicate cervical spinal system – the AXIS® Fixation System (primary predicate) cleared by the FDA in K062254 (SE 06/16/08). The subject device is also equivalent to the previously cleared VERTEX® devices most recently cleared in K123906 (SE 04/01/2013) and in K123568 (SE 02/25/13) with respect to the implants used to create the constructs utilized for the indications sought. The earlier VERTEX® Reconstruction System clearances are noted for reference purposes only and not as a predicate device for this application.
Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing:
Retrospective clinical data provided in support of this application along with the published clinical outcomes of additional patients treated with the VERTEX® device for the indications sought, demonstrates the subject device is substantially equivalent to the AXIS® Fixation System when used to treat the aforementioned indications. Mechanical testing was also provided to support a substantial equivalence determination of the subject VERTEX® Reconstruction System. Testing consisted of the following:
Unblocked Compression Fatigue and Static Compression Testing of Multi-Axial Screws (MAS) -ASTM F1717
Semi-Blocked Torsion Fatigue and Static Torsion Testing of Occipital Cervical Module with MAS – ASTM F2706
5
Conclusion: The design features, materials used, indications for use, surgical approach, manufacturing methods and sterilization methods are substantially equivalent to the previously cleared AXIS® Fixation System. The mechanical testing and clinical data provided demonstrate the substantial equivalence of the subject VERTEX® Reconstruction System compared to the predicate AXIS® Fixation System.