(126 days)
Not Found
No
The summary describes a physical implant system and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an anterior cervical interbody fusion system designed to treat cervical disc disease, facilitating fusion and alleviating symptoms in patients who have failed non-operative treatment.
No
The provided text describes a surgical implant system (NuVasive CoRoent Small Interlock System) intended for anterior cervical interbody fusion. It is used to treat cervical disc disease by facilitating fusion and providing stabilization. The text focuses on the device's materials, sizes, indications for use, and performance testing related to its structural integrity and equivalency to other surgical implants. There is no mention of the device being used to identify, classify, or characterize a disease or condition, which are functions of a diagnostic device.
No
The device description explicitly states it is a system consisting of a PEEK implant cage, titanium alloy and tantalum markers, washers, and bone fixation screws, which are all hardware components.
Based on the provided text, the NuVasive CoRoent Small Interlock System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the NuVasive CoRoent Small Interlock System clearly states it is an anterior cervical interbody fusion system, which is an implantable medical device used in surgery.
- The intended use and device description focus on its function as a physical implant for spinal fusion, not on analyzing biological samples.
Therefore, this device falls under the category of a surgical implant or medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive CoRoent Small Interlock System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The NuVasive CoRoent Small Interlock System (lordotic angles of 10° and 15°) is a standalone system. The NuVasive CoRoent Small Interlock System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
Product codes
OVE
Device Description
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with titanium alloy and tantalum radiographic markers, titanium alloy washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, titanium alloy conforming to ASTM F136 and tantalum conforming to ASTM F560 or ISO 13782. The implants are available in a variety of sizes to accommodate anatomical conditions. The NuVasive CoRoent Small Interlock System is a standalone system intended to be used with the bone screws provided, and when used as such requires no additional supplementary fixation systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical disc
Indicated Patient Age Range
skeletally mature patients
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
Nonclinical testing was performed to demonstrate that the subject NuVasive CoRoent Small Interlock System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic compression testing per ASTM F2077
- Static and dynamic torsion testing per ASTM F2077
- Wear debris/mass change analysis during ASTM F2077, per ASTM F1877 and ASTM F1714
- Static push-out testing per ASTM Work Item Z8423Z
- Subsidence analysis per ASTM F2267
The results of these studies show that the subject NuVasive CoRoent Small Interlock System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K142299, K102547, K140921, K081611, K131025
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human figures, possibly representing individuals or families, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2016
NuVasive, Incorporated Ms. Cynthia Adams Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121
Re: K161442
Trade/Device Name: NuVasive® CoRoent® Small Interlock™ System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: September 8, 2016 Received: September 9, 2016
Dear Ms. Adams:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
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) K161442
Device Name
NuVasive® CoRoent® Small Interlock™ System
Indications for Use (Describe)
The NuVasive CoRoent Small Interlock System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The NuVasive CoRoent Small Interlock System (lordotic angles of 10° and 15°) is a standalone system. The NuVasive CoRoent Small Interlock System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
| 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) |
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Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in purple.
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:
Cynthia Adams Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: September 14, 2016
B. Device Name
| Trade or Proprietary Name: | NuVasive® CoRoent® Small Interlock™ System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | OVE |
C. Predicate Devices
The subject NuVasive CoRoent Small Interlock System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interlock System (K142299) serves as the primary predicate device, while NuVasive CoRoent Interlock System (K102547) is an additional predicate device. NuVasive CoRoent Small Interbody System (K140921), NuVasive CoRoent System (K081611) and NuVasive Archon Anterior Cervical System (K131025) are additional predicate devices.
D. Device Description
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with titanium alloy and tantalum radiographic markers, titanium alloy washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, titanium alloy conforming to ASTM F136 and tantalum conforming to ASTM F560 or ISO 13782. The implants are available in a variety of sizes to accommodate anatomical conditions. The NuVasive CoRoent Small Interlock System is a standalone system intended to be used with the bone screws provided, and when used as such requires no additional supplementary fixation systems.
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Image /page/4/Picture/0 description: The image is a logo for Nuvasive. The logo features a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray, block letters. Underneath the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller, purple font.
Indications for Use E.
The NuVasive CoRoent Small Interlock System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The NuVasive CoRoent Small Interlock System (lordotic angles of 10° and 15°) is a standalone system. The NuVasive CoRoent Small Interlock System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
F. Technological Characteristics
As was established in this submission, the subject NuVasive CoRoent Small Interlock 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 the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NuVasive CoRoent Small Interlock System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic compression testing per ASTM F2077 ●
- Static and dynamic torsion testing per ASTM F2077 ●
- Wear debris/mass change analysis during ASTM F2077, per ASTM F1877 and ASTM F1714
- Static push-out testing per ASTM Work Item Z8423Z ●
- Subsidence analysis per ASTM F2267 ●
The results of these studies show that the subject NuVasive CoRoent Small Interlock System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject NuVasive CoRoent Small Interlock System has been shown to be substantially equivalent to legally marketed predicate devices.