(90 days)
Not Found
No
The summary describes a passive implant system (screws and plates) and associated manual instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on material properties and MR compatibility.
Yes.
The device is intended for anterior screw fixation of the cervical spine to treat conditions such as degenerative disc disease, trauma, tumors, and spinal stenosis, with the aim of providing stabilization as an adjunct to cervical fusion. These applications clearly indicate a therapeutic purpose.
No
This device is an anterior cervical plating system intended for stabilization as an adjunct to cervical fusion, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of "a variety of implant components including screws and plates, as well as associated manual general surgical instruments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for anterior screw fixation of the cervical spine for various conditions like degenerative disc disease, trauma, tumors, etc. This is a surgical implant used directly on the patient's body.
- Device Description: The device description details the components as screws and plates made of titanium and nickel-cobalt-chromium-molybdenum alloy. These are physical implants.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The NuVasive Anterior Cervical Plate Systems are surgical implants used in vivo (within the body) to stabilize the cervical spine. They do not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The Nu Vasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of the implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. Additionally, the three-hale version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomies for the treatment of tumors and burst fractures.
The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
The NuVasive HELIX Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The NuVasive Anterior Cervical Plate Systems are anterior cervical plating systems that consist of a variety of implant components including screws and plates, 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 devices components are from titanium (Ti-6A1-4V) conforming to ASTM F1472/F136 and ISO 5832-3, (titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 or ISO 5832-3, and nickel-cobalt-chromium-molybdenum alloy (MP35N) per ASTM F562.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine C2-C7
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)
Testing to assess the safety and compatibility of subject devices in the Magnetic Resonance (MR) Environment was presented. Below is the list Magnetic resonance imaging (MRI) compatibility testing that were conducted as per the FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014 and the standards:
- Magnetically induced displacement force (ASTM F2052)
- Magnetically induced torque (ASTM F2213)
- Radiofrequency (RF) induced heating (ASTM F2182)
- MR image artifact (ASTM F2119)
Additionally, sterile packaging validations for the Helix ACP System were executed for purpose of this submission.
The results of these studies show that the subject NuVasive Anterior Cervical Plate Systems meet or exceed the performance of the predicate devices and do not introduce any new risks; therefore, the systems are substantially equivalent to the predicate devices.
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.
K071329, K073275, K083341, K093804, K203253, K122910, K131025, K053581
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
November 3, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG" are in a blue sans-serif font, with "ADMINISTRATION" in a smaller font below.
NuVasive, Incorporated Priscila Saraiva Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
Re: K212446
Trade/Device Name: NuVasive® Anterior Cervical Plate Systems Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 4, 2021 Received: August 5, 2021
Dear Priscila Saraiva:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 mediation-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 DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K212446
Device Name NuVasive® ACP System
Indications for Use (Describe)
The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
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
3
510(k) Number (if known) K212446
Device Name
NuVasive Archon® Anterior Cervical Plate System
Indications for Use (Describe)
The Nu Vasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of the implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. Additionally, the three-hale version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomies for the treatment of tumors and burst fractures.
WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
| 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
4
510(k) Number (if known) K212446
Device Name
NuVasive® SmartPlate Gradient Plus System
Indications for Use (Describe)
The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive SmartPlate Gradient Plus System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
| 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
5
510(k) Number (if known) K212446
Device Name
NuVasive® HELIX Anterior Cervical Plating System
Indications for Use (Describe)
The NuVasive HELIX Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive HELIX Anterior Cervical Plating System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
| 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
6
Image /page/6/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, with the word "NUVASIVE" in gray letters to the right of the shape. The leaf-like shape is divided into two parts, with the top part being a dark purple color and the bottom part being a light gray color.
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. Priscila Saraiva Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 909-1807
Date Prepared: August 4, 2021
B. Device Name
| Trade or Proprietary Name: | NuVasive® Anterior Cervical Plate Systems |
|---|---|
| Common or Usual Name: | Anterior Cervical Plate and Screw System |
| Regulation Name: | Spinal Intervertebral Body Fixation Orthosis |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR § 888.3060 |
| Product Code: | KWQ |
C. Predicate Devices
The subject NuVasive Anterior Cervical Plate Systems are substantially equivalent to the following devices:
Primary Predicate
-
K071329 – NuVasive Helix ACP System
Additional Predicates -
K073275 NuVasive Helix Mini ACP System ●
-
K083341 NuVasive Helix-T Anterior Cervical Plate System ●
-
K093804 NuVasive Helix Revolution ACP System ●
-
K203253 NuVasive ACP System ●
-
K122910 NuVasive Archon Anterior Cervical PlateSystem ●
-
K131025 NuVasive Archon Anterior Cervical PlateSystem ●
-
K053581 – NuVasive SmartPlate Gradient Plus System
D. Device Description
The NuVasive Anterior Cervical Plate Systems are anterior cervical plating systems that consist of a variety of implant components including screws and plates, 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 devices components are from titanium (Ti-6A1-4V) conforming to ASTM F1472/F136 and ISO 5832-3, (titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 or ISO 5832-3, and nickel-cobalt-chromium-molybdenum alloy (MP35N) per ASTM F562.
7
Image /page/7/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf-like shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The leaf shape is partially transparent, with the purple and gray sections overlapping. The font of the wordmark is sans-serif and modern.
Testing to assess the safety and compatibility of subject devices in the Magnetic Resonance (MR) Environment is in scope of this submission along with introducing sterile packaging to the Helix ACP System.
E. Indications for Use
The NuVasive HELIX Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive HELIX Anterior Cervical Plating System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The NuVasive ACP System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The NuVasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. Additionally, the threehole version of the implant system may be appropriate only for patients with large vertebral bodies and is particularly suited for use following corpectomies for the treatment of tumors and burst fractures.
WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical. thoracic or lumbar spine.
The NuVasive Gradient Plus Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive Gradient Plus System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
8
F. Technological Characteristics
As was established in this submission, the subject NuVasive Anterior Cervical Plate Systems are substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject devices were 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.
G. Performance Data
Testing to assess the safety and compatibility of subject devices in the Magnetic Resonance (MR) Environment was presented. Below is the list Magnetic resonance imaging (MRI) compatibility testing that were conducted as per the FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014 and the standards:
-
- Magnetically induced displacement force (ASTM F2052)
-
- Magnetically induced torque (ASTM F2213)
-
- Radiofrequency (RF) induced heating (ASTM F2182)
-
- MR image artifact (ASTM F2119)
Additionally, sterile packaging validations for the Helix ACP System were executed for purpose of this submission.
The results of these studies show that the subject NuVasive Anterior Cervical Plate Systems meet or exceed the performance of the predicate devices and do not introduce any new risks; therefore, the systems are substantially equivalent to the predicate devices.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive Anterior Cervical Plate Systems have been shown to be substantially equivalent to legally marketed predicate devices.