(16 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical properties and materials of a spinal reconstruction system, with no mention of AI or ML.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various conditions, which are therapeutic interventions.
No
The VERTEX™ Reconstruction System is described as a posterior implant system for spinal fusion and stabilization, not a device for diagnosing medical conditions. Its intended use is to provide immobilization and restore the integrity of the spinal column, not to identify or analyze diseases.
No
The device description explicitly states it consists of physical components like plates, rods, hooks, and screws made from titanium alloy and cobalt chromium, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the spine. It is used in the body to treat structural issues, not to perform tests on samples taken from the body.
- Device Description: The description details physical components like plates, rods, hooks, and screws, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The VERTEX™ Reconstruction System is a therapeutic device used in surgery.
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 fraumatic 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 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 (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. Conditions of the cervical spine, such as degenerative disease, tumor, or trauma, can lead to instability and pain for patients. In order to treat the instability, surgeons may need to use implants to reconstruct the spine. The VERTEX™ Reconstruction System is a comprehensive set of options that provides adjustability, flexibility, and adaptability to meet the anatomical challenges of the occipitocervical and upper thoracic spine. The VERTEX™ Reconstruction System is intended to be implanted by an orthopedic surgeon as described in the Surgical Technique. Each construct is specifically designed for each individual case. The components of the VERTEX™ Reconstruction System are fabricated from medical grades of commercially pure titanium alloy, and cobalt chromium. The VERTEX™ Reconstruction System also includes a retaining ring for the use with the multi-axial screw which is fabricated from Shape Memory Alloy, Nitinol-NiTi.
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 to C7) and the thoracic spine from T1-T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeon
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)
Biocompatibility: The subject VERTEX™ Reconstruction System implants are permanent implants (> 30 days) and will be classified as body contacting devices according to FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The subject implants and instruments are manufactured from identical materials as the predicate devices, in accordance with the following standards:
- ASTM F136: Standard Specification for Wrought Ti-6A1-4V ELI Alloy for Surgical Implant
- ASTM F1537: Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants
The materials used for manufacturing the subject device have a long history of safe and effective use in predicate spinal implants, and biocompatibility testing is not required.
Mechanical Testing: Non-clinical mechanical testing was not performed on the sterile implants. The subject implants are the same as the predicate devices in terms of material, diameter, sizes and intended use. The predicate rods were tested in accordance to ASTM F1717. The subject devices do not introduce a new worst case, hence testing conducted on predicate rods is sufficient for subject rods. Medtronic believes that the subject implants do not introduce a new worst case scenario and are substantially equivalent to the predicate device.
Non-Pyrogenicity Endotoxin Testing: The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP , Medical Devices – Bacterial Endotoxin and Pyrogen Tests.
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.
K152338, K123656, K003780, K052402, K070742, K080805, K163375
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.
No reference devices were used in this submission.
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
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.
Medtronic Sofamor Danek USA. Inc Mr. Ankit Shah Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K180851
Trade/Device Name: VERTEX™ Reconstruction System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: March 29, 2018 Received: April 2, 2018
Dear Mr. Shah:
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.
1
(1-800-638-2041 or 301-796-7100).
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
Sincerely,
Colin O'neill -S
for M
for MNM
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)
K180851
Device Name VERTEXTM 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 fraumatic 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 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)|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 March 2018
| I. Company: | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone Number: (901) 396-3133 |
|-------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ankit K. Shah
Sr. Regulatory Affairs Specialist
Telephone number: (901) 396-3133
Email: ankit.k.shah@medtronic.com |
| Date: | 29 March 2018 |
- Proprietary Trade Name: VERTEX™ Reconstruction System II. Classification Name: Orthosis, Cervical Pedicle Screw Spinal Fixation (Unclassified) Classification: Pre-Amendment Product Code: NKG Classification Name: Appliance, Fixation, Spinal Interlaminal (21 CFR§ 888.3050) Classification: Class II Product Code: KWP
Predicate Device: III.
Primary Predicate
-
K152338 VERTEX™ Reconstruction System (S.E.10/28/2015) .
Additional Predicates -
K123656 VERTEX™ Reconstruction System (S.E.02/25/2013) ●
-
K003780 VERTEX™ Reconstruction System (S.E. 09/28/2001) ●
-
K052402 VERTEX™ Reconstruction System (S.E. 09/23/2005) o
-
K070742 VERTEX™ Reconstruction System (S.E. 09/14/2007) ●
-
K080805 VERTEX™ Reconstruction System (S.E. 04/18/2008) o
-
K163375 INFINITY™ OCT System (S.E. 08/21/2017) ●
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These predicates have not been subject to a design-related recall. No reference devices were used in this submission.
Device Description: IV.
The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. Conditions of the cervical spine, such as degenerative disease, tumor, or trauma, can lead to instability and pain for patients. In order to treat the instability, surgeons may need to use implants to reconstruct the spine. The VERTEX™ Reconstruction System is a comprehensive set of options that provides adjustability, flexibility, and adaptability to meet the anatomical challenges of the occipitocervical and upper thoracic spine. The VERTEX™ Reconstruction System is intended to be implanted by an orthopedic surgeon as described in the Surgical Technique. Each construct is specifically designed for each individual case. The components of the VERTEX™ Reconstruction System are fabricated from medical grades of commercially pure titanium alloy, and cobalt chromium. The VERTEX™ Reconstruction System also includes a retaining ring for the use with the multi-axial screw which is fabricated from Shape Memory Alloy, Nitinol-NiTi.
V. 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 time period in patients with advanced stage tumors
5
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.
VI. Summary of the Technological Characteristics:
The subject rods have identical indications, intended use, fundamental scientific technology, materials, dimensions and design features as the VERTEX™ Reconstruction System predicates previously cleared by FDA in; K152338 (S.E. 10/28/2015), K123656 (S.E. 02/25/2013), K003780 (S.E. 09/28/2001), K052402 (S.E. 09/23/2005), K070742 (S.E. 09/14/2007), K080805 (S.E. 04/18/2008). Like the predicate rods, the subject rods are available in titanium alloy and cobalt chromium alloy. The only technological difference between the subject and predicate VERTEX™ Reconstruction System devices is as below: The subject VERTEX™ rods are provided sterile while the predicate VERTEX™ rods are provided non-sterile. The sterilization method used for subject rods, is identical to recently cleared rods within the Infinity OCT System K163375 (S.E. 08/21/2017).
Performance Data: VII.
The following information is provided in support of substantial equivalence.
Biocompatibility
The subject VERTEX™ Reconstruction System implants are permanent implants (> 30 days) and will be classified as body contacting devices according to FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The subject implants and instruments are manufactured from identical materials as the predicate devices, in accordance with the following standards:
6
- ASTM F136: Standard Specification for Wrought Ti-6A1-4V ELI Alloy for 0 Surgical Implant
- o ASTM F1537: Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants
The materials used for manufacturing the subject device have a long history of safe and effective use in predicate spinal implants, and biocompatibility testing is not required.
Mechanical Testing
Non-clinical mechanical testing was not performed on the sterile implants. The subject implants are the same as the predicate devices in terms of material, diameter, sizes and intended use. The predicate rods were tested in accordance to ASTM F1717. The subject devices do not introduce a new worst case, hence testing conducted on predicate rods is sufficient for subject rods. Medtronic believes that the subject implants do not introduce a new worst case scenario and are substantially equivalent to the predicate device.
Non-Pyrogenicity Endotoxin Testing
The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP , Medical Devices – Bacterial Endotoxin and Pyrogen Tests.
VIII. Conclusions:
Based on the sterilization assessment, packaging assessment, and additional supporting documentation provided in this pre-market notification, the subject VERTEX™ Reconstruction System implants demonstrate substantial equivalence to the previously listed predicate devices.