(42 days)
Not Found
No
The device description and performance studies section indicate this is a mechanical implant system with no mention of software, algorithms, or data processing that would suggest AI/ML.
Yes.
The device is indicated for the treatment of spine instability resulting from various conditions like fracture, tumor, degenerative disc disease, scoliosis, etc., which implies it is used to alleviate or treat these medical conditions.
No
The device is a system of plates, bolts, screws, and surgical instruments intended for the treatment of spine instability. It is a surgical implant designed to provide stabilization, not to diagnose a condition.
No
The device description explicitly states it consists of physical implant components (plates, bolts, screws) and surgical instruments made from titanium alloy and other materials. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed 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 NuVasive Thoracolumbar Plates system consists of "implant components including plates, bolts and screws, as well as associated manual general surgical instruments." These are physical devices implanted into the body.
- Intended Use: The intended use describes the surgical application of these implants to treat spine instability resulting from various conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant system used to stabilize the spine, which is a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nu Vasive Decade Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.
The Nu Vasive Brigade Anterior Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spondylolysis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.
The NuVasive Traverse Plate System is indicated for use via the lateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The NuVasive Thoracolumbar Plates is a lateral or anterolateral thoracolumbar plating system that consists of a variety of implant components including plates, bolts and screws, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3. In addition, the Brigade Anterior Plate System also includes a Nitinol Spring Lock (NSL) manufactured from Nickel-Titanium alloy (Nitinol SE508) per ASTM F2063, and the Traverse Plate System (2+2 Compression Plate and 4-Screw Hole Fixed Plate only) includes a canted coil locking mechanism manufactured from Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (TI-L5) spine, lumbar and lumbosacral (L1-S1) spine
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)
No new NuVasive Thoracolumbar Plates implant designs are being introduced to the previously cleared Decade Lateral Plate System (K130868), Brigade Anterior Plate System (K121837) and Traverse Plate System (K103750) implants. However, minor design modifications were made to certain devices within the Decade Lateral Plate System (K130868) and Traverse Plate System (K103750) systems via add-tofile. We include the confirmatory mechanical testing that shows that the minor design modifications do not create a new worst case that would require new or additional testing. Since spondylolysis and spondylolisthesis use does not change the biomechanical stresses placed upon the individual implants, additional non-clinical testing is unwarranted. Therefore, no performance testing was performed for this 510(k) submission and the worst case devices included with the subject system were tested and cleared in predicate 510(k) submissions. Only previously cleared devices are the subject of this submission, i.e., there is no new worst case 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.
K180166, K130868, K121837, K103750
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
May 21, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
NuVasive, Incorporated Daniela Mahan Senior Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
Re: K200956
Trade/Device Name: NuVasive Thoracolumbar Plates Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 8, 2020 Received: April 9, 2020
Dear Daniela Mahan:
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. Assistant Director (Acting) 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
NuVasive Thoracolumbar Plates (NuVasive Decade Lateral Plate System)
Indications for Use (Describe)
The Nu Vasive Decade Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.
| 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
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
NuVasive Thoracolumbar Plates (NuVasive Brigade Anterior Plate System)
Indications for Use (Describe)
The Nu Vasive Brigade Anterior Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spondylolysis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.
| 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) |
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."
4
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
NuVasive Thoracolumbar Plates (NuVasive Traverse Plate System)
Indications for Use (Describe)
The NuVasive Traverse Plate System is indicated for use via the lateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.
| 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."
5
Image /page/5/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. The leaf shape is on the left side of the logo, and the word "NUVASIVE" is on the right side.
Appendix 1 510(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:
A. Submitted by:
Ms. Daniela Mahan, Esq., RAC Sr. Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 458-2285
Date Prepared: May 18, 2020
B. Device Name
| Trade or Proprietary Name: | NuVasive Thoracolumbar Plates:
NuVasive Decade Lateral Plate System
NuVasive Brigade Anterior Plate System
NuVasive Traverse Plate System |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Spinal Implant |
| Classification Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3060 |
| Product Code: | KWQ |
C. Predicate Devices
The subject NuVasive Thoracolumbar Plates is substantially equivalent to the following devices:
Primary Predicate Device:
| Product Name | 510(k)
Number | Date of FDA-
Clearance |
|--------------------------------------------------------|------------------|---------------------------|
| Life Spine Anterior Lumbar Fixation System
(Sentry) | K180166 | 6/22/2018 |
Additional Predicate Devices:
| Product Name | 510(k)
Number | Date of FDA-
Clearance |
|----------------------------------------|------------------|---------------------------|
| NuVasive Decade Lateral Plate System | K130868 | 8/29/2013 |
| NuVasive Brigade Anterior Plate System | K121837 | 7/16/2012 |
| NuVasive Traverse Plate System | K103750 | 3/3/2011 |
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Image /page/6/Picture/0 description: The image shows the logo for NuVasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf is split into two colors, with the top half being purple and the bottom half being gray.
D. Device Description
The NuVasive Thoracolumbar Plates is a lateral or anterolateral thoracolumbar plating system that consists of a variety of implant components including plates, bolts and screws, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3. In addition, the Brigade Anterior Plate System also includes a Nitinol Spring Lock (NSL) manufactured from Nickel-Titanium alloy (Nitinol SE508) per ASTM F2063, and the Traverse Plate System (2+2 Compression Plate and 4-Screw Hole Fixed Plate only) includes a canted coil locking mechanism manufactured from Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562.
E. Indications for Use
The NuVasive Decade Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolysis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.
The NuVasive Brigade Anterior Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolysis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.
The NuVasive Traverse Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor. degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.
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Image /page/7/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is split into two parts, with the top part being purple and the bottom part being gray.
F. Technological Characteristics
As was established in this submission, the subject NuVasive Thoracolumbar Plates is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.
Performance Data G.
The purpose of the submission is to expand indications to include the treatment of spondylolysis and spondylolisthesis, and clarifying that failed previous spine surgery includes pseudarthrosis. No new NuVasive Thoracolumbar Plates implant designs are being introduced to the previously cleared Decade Lateral Plate System (K130868), Brigade Anterior Plate System (K121837) and Traverse Plate System (K103750) implants. However, minor design modifications were made to certain devices within the Decade Lateral Plate System (K130868) and Traverse Plate System (K103750) systems via add-tofile. We include the confirmatory mechanical testing that shows that the minor design modifications do not create a new worst case that would require new or additional testing. Since spondylolysis and spondylolisthesis use does not change the biomechanical stresses placed upon the individual implants, additional non-clinical testing is unwarranted. Therefore, no performance testing was performed for this 510(k) submission and the worst case devices included with the subject system were tested and cleared in predicate 510(k) submissions. Only previously cleared devices are the subject of this submission, i.e., there is no new worst case device.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive Thoracolumbar Plates has been shown to be substantially equivalent to legally marketed predicate devices.