(69 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical technique of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a temporary implant for use in orthopedic surgery, intended to provide temporary stabilization and aid in the repair of bone fractures, and is used in various spinal surgeries to correct deformities and assist fusions. These actions directly contribute to healing or preventing disease, which is the definition of a therapeutic device.
No
Explanation: The NuVasive VersaTie System is described as a temporary implant for use in orthopedic surgery, intended to provide temporary stabilization and aid in the repair of bone fractures. Its function is to secure other implants or provide stabilization during fusion, not to diagnose medical conditions or diseases.
No
The device description explicitly states the system is comprised of "braided bands and clamps" and "Implant components are available in a variety sizes," indicating it is a physical implant system, not software.
Based on the provided information, 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 and Intended Use: The NuVasive VersaTie System is described as a temporary implant used in orthopedic surgery to provide temporary stabilization and aid in bone repair and fusion. It is a physical device implanted into the body.
- Lack of Biological Sample Testing: There is no mention of the device interacting with or analyzing biological samples from the patient.
Therefore, the NuVasive VersaTie System falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The NuVasive® VersaTie™ System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions.
The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium alloy whenever "wiring" may help secure the attachment of other implants.
Product codes
OWI
Device Description
The NuVasive VersaTie System is part of a spinal fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, transverse processes, and spinous process from T1-L5. The system is comprised of braided bands and clamps designed to attach to titanium alloy or cobalt-chromium alloy rods. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce an additional surgical technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior vertebral structures such as the lamina, facet, transverse processes, and spinous process from T1-L5.
Indicated Patient Age Range
patients 8 years of age or older
Intended User / Care Setting
orthopedic surgery, spinal trauma surgery, spinal reconstructive surgery, spinal degenerative surgery
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
Nonclinical testing was performed to demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate device. The following testing was performed:
- Static and dynamic Anterior-Posterior band pull-through testing ●
- Static and dynamic Caudal-Cranial band pull-through testing
The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
December 7, 2017
NuVasive, Inc. Ms. Olga Lewis Senior Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K173117
Trade/Device Name: NuVasive® VersaTie™ System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: December 4, 2017 Received: December 6, 2017
Dear Ms. Lewis:
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 (OS) 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
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 medical devices and radiation-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 (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173117
Device Name NuVasive® VersaTie™ System
Indications for Use (Describe)
The NuVasive® VersaTie™ System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions.
The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium alloy whenever "wiring" may help secure the attachment of other implants.
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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3
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:
Olga Lewis Senior Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: December 4, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® VersaTie™ System |
|---|---|
| Common or Usual Name: | Bone Fixation Cerclage, Sublaminar |
| Classification Name: | Bone Fixation Cerclage |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3010 |
| Product Code: | OWI |
C. Predicate Devices
The subject device is substantially equivalent to the primary predicate device NuVasive VersaTie System cleared in K161265.
D. Device Description
The NuVasive VersaTie System is part of a spinal fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, transverse processes, and spinous process from T1-L5. The system is comprised of braided bands and clamps designed to attach to titanium alloy or cobalt-chromium alloy rods. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce an additional surgical technique.
E. Intended Use
The NuVasive® VersaTie™ System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis;
-
- Spinal degenerative surgery, as an adjunct to spinal fusions.
4
Image /page/4/Picture/0 description: The image shows the Nuvasive company logo. The logo consists of a stylized leaf shape in purple and gray, followed by the company name "NUVASIVE" in gray. The logo is simple and modern, and the colors are muted and professional.
The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium alloy whenever "wiring" may help secure the attachment of other implants.
F. Technological Characteristics
As was established in this submission, the subject NuVasive VersaTie System 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 equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
Performance Data G.
Nonclinical testing was performed to demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate device. The following testing was performed:
- Static and dynamic Anterior-Posterior band pull-through testing ●
- Static and dynamic Caudal-Cranial band pull-through testing
The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate.
H. Conclusions
The subject NuVasive VersaTie System has been shown to be substantially equivalent to a legally marketed predicate devices for its intended use.