(123 days)
Not Found
No
The summary describes a passive implantable device for spinal fusion. There is no mention of any computational or analytical capabilities, let alone AI/ML. The purpose of the submission is to add a manufacturer, further indicating no change in the device's core technology.
Yes
The device is indicated for intervertebral body fusion of the spine, treatment of symptomatic disc degenerative spondylolisthesis, and multilevel degenerative scoliosis, which are all therapeutic interventions aimed at treating medical conditions.
No
The device is an interbody fusion system designed to facilitate spinal fusion, not to diagnose medical conditions.
No
The device description clearly states it is manufactured from physical materials (PEEK, titanium, tantalum) and is an implantable device with physical features like teeth and radiographic pins. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a surgical implant (an intervertebral body fusion device) made of various materials (PEEK, titanium, tantalum) designed to be placed in the spine to facilitate fusion. Its purpose is structural support and promoting bone growth, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing specimens, using reagents, or providing diagnostic information based on laboratory tests.
This device is a surgical implant used in a surgical procedure.
N/A
Intended Use / Indications for Use
The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent Ti-C System (XL platform) is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the CoRoent (XL and L platforms) are intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent Ti-C System (XL and L platforms) are also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.
Product codes
MAX
Device Description
The NuVasive CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) LT1 conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, Ti-6Al-4V ELI conforming to ASTM F136/1472 or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. The implant contains a hollow core or graft aperture which allows for packing of bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Radiographic pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The purpose of this 510(k) submission is to add a manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the lumbar spine, from L1 to S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Nonclinical testing was performed to demonstrate that the subject CoRoent Ti-C System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear per ASTM F2077
- Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877 ●
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011 ●
The results demonstrate that the subject CoRoent Ti-C System presents no new worst-case for performance testing, and meets the requirements as outlined in the Agency's guidance, "Submission and Review of Sterility Information in Premarket Notification (510(K)) Submissions for Devices Labeled as Sterile". For the above reasons, the subject device was therefore found to be substantially equivalent to the predicates. No animal or clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2017
Nuvasive, Incorporated Cynthia Adams Regulatory Affairs Specialist 7475 Lusk Blvd. San Diego, California 92121
Re: K163707
Trade/Device Name: NuVasive Coroent Ti-C System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 5, 2017 Received: April 6, 2017
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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" (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 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)
Device Name NuVasive CoRoent Ti-C System
Indications for Use (Describe)
The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent Ti-C System (XL platform) is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the CoRoent (XL and L platforms) are intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent Ti-C System (XL and L platforms) are also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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 contains the logo for "NUVASIVE". The logo consists of a stylized purple and gray graphic on the left, resembling a leaf or abstract shape. To the right of the graphic is the word "NUVASIVE" in a light gray, sans-serif font. The overall design is clean and modern.
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 Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4549
Date Prepared: December 28, 2016
B. Device Name
| Trade or Proprietary Name: | NuVasive CoRoent Ti-C System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Lumbar |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | MAX |
C. Predicate Devices
The subject NuVasive CoRoent Ti-C System is substantially equivalent to the primary predicate, NuVasive Lumbar Interbody Implants (K161230), and the additional predicates, NuVasive CoRoent Ti-C System (K160916) and NuVasive CoRoent Ti-C System (K140319).
D. Device Description
The NuVasive CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) LT1 conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, Ti-6Al-4V ELI conforming to ASTM F136/1472 or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. The implant contains a hollow core or graft aperture which allows for packing of bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Radiographic pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The purpose of this 510(k) submission is to add a manufacturer.
E. Intended Use
The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous
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Image /page/4/Picture/1 description: The image contains the logo for Nuvasive. The logo consists of a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, sans-serif font. The graphic appears to be an abstract representation of a leaf or a curved shape.
bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent Ti-C System (XL platform) is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the CoRoent Ti-C System (XL and L platforms) are intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent Ti-C System (XL and L platforms) are also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.
F. Technological Characteristics
As was established in this submission, the subject CoRoent Ti-C 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 Ti-C System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear per ASTM F2077
- Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877 ●
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011 ●
The results demonstrate that the subject CoRoent Ti-C System presents no new worst-case for performance testing, and meets the requirements as outlined in the Agency's guidance, "Submission and Review of Sterility Information in Premarket Notification (510(K)) Submissions for Devices Labeled as Sterile". For the above reasons, the subject device was therefore found to be substantially equivalent to the predicates. No animal or clinical studies were conducted.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CoRoent Ti-C System has been shown to be substantially equivalent to legally marketed predicate devices.