(91 days)
No
The 510(k) summary describes a physical interbody fusion device and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing and literature review, not algorithmic performance.
Yes
This device is an implantable intervertebral body fusion device and a partial vertebral body replacement device, which are inherently therapeutic in nature as they treat conditions like degenerative disc disease, tumors, or fractures of the spine to restore function and relieve symptoms.
No
This device is an intervertebral body fusion device and a partial vertebral body replacement device, which are therapeutic implants, not diagnostic tools.
No
The device description explicitly states the device is manufactured from physical materials (PEEK-Optima® LT-1, titanium alloy, tantalum) and is available in different shapes and sizes, indicating it is a physical implant, 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this device is an implantable system used for intervertebral body fusion and partial vertebral body replacement in the spine. It is a physical device implanted into the body to provide structural support and facilitate fusion.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition based on in vitro testing.
Therefore, the NuVasive CoRoent Small Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intervertebral Body Fusion
The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is designed for use with autogenous 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.
Partial Vertebral Body Replacement
The NuVasive CoRoent Small Interbody System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Product codes
MQP, ODP
Device Description
The NuVasive CoRoent Small Interbody System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, and titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (C2 - T1), thoracolumbar spine (T1 to L5)
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 CoRoent Small Interbody System is substantially equivalent to other predicate devices. The following testing/analysis was performed:
- Static and dynamic axial compression per ASTM F2077 .
- Static and dynamic torsion per ASTM F2077 .
- Subsidence Analysis per ASTM F2267 .
- Clinical literature review .
The results of these studies demonstrate that the subject CoRoent Small Interbody System meets or exceeds the performance of the predicate device, and the subject device was therefore found to be substantially equivalent. No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
NuVasive CoRoent System (K081611), Maxim Surgical X-Treme Interbody Fusion System (K123206), and Spinal USA Anterior Cervical Interbody Fusion Device (K083118).
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 Nuvasive logo. The logo consists of a stylized graphic element on the left, resembling an abstract shape, followed by the word "NUVASIVE" in a clean, sans-serif font. Below "NUVASIVE" is the tagline "Speed of Innovation" in a smaller, italicized font.
Traditional 510(k) Premarket Notification NuVasive® CoRoent® Small Interbody System
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:
Submitted by: A.
Cynthia Adams Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: March 31, 2014
B. Device Name
| Trade or Proprietary Name: | NuVasive® CoRoent® Small Interbody System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Bone Graft, |
| cervical | |
| Spinal Vertebral Body Replacement Device | |
| Device Class: | Class II |
I Classification: Product Code:
21 CFR § 888.3060, § 888.3080 MQP, ODP
் Predicate Devices
The subject CoRoent Small Interbody System is substantially equivalent to the following predicate devices: NuVasive CoRoent System (K081611), Maxim Surgical X-Treme Interbody Fusion System (K123206), and Spinal USA Anterior Cervical Interbody Fusion Device (K083118).
Device Description D.
The NuVasive CoRoent Small Interbody System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, and titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
APR 0 3 2014
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Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized, abstract shape on the left, followed by the word "NUVASIVE" in a simple, sans-serif font. Below the company name is the tagline "Speed of Innovation" in a smaller font size.
Traditional 510(k) Premarket Notification NuVasive® CoRoent® Small Interbody System
E. Intended Use
Intervertebral Body Fusion
The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is designed for use with autogenous 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.
Partial Vertebral Body Replacement
The NuVasive CoRoent Small Interbody System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
F. Technological Characteristics
As was established in this submission, the subject CoRoent Small Interbody 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 CoRoent Small Interbody. System is substantially equivalent to other predicate devices. The following testing/analysis was performed:
- Static and dynamic axial compression per ASTM F2077 .
- Static and dynamic torsion per ASTM F2077 .
- Subsidence Analysis per ASTM F2267 .
- Clinical literature review .
The results of these studies demonstrate that the subject CoRoent Small Interbody System meets or exceeds the performance of the predicate device, and the subject device was therefore found to be substantially equivalent. No clinical studies were conducted.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CoRoent Small Interbody System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
NuVasive, Incorporated Ms. Cynthia Adams Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K140003
Trade/Device Name: NuVasive® CoRoent® Small Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: March 12, 2014 Received: March 13, 2014
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Cynthia Adams
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 requlation 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance 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 yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K140003
Device Name
NuVasive® CoRoent® Small Interbody System
Indications for Use (Describe)
Intervertebral Body Fusion
The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is designed for use with autogenous 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.
Partial Vertebral Body Replacement
The NuVasive CoRoent Small Interbody System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (TI to LS) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Type of Use (Select one or both, as applicable)
2 Prescription Use {Part 21 CFR 801 Subpart D)
J Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . . . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev. PhD
Divisio
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