(87 days)
Not Found
No
The device description focuses on the materials and mechanical properties of spinal implants, with no mention of AI or ML capabilities. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is indicated for intervertebral body fusion of the spine for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis, which are medical conditions, and is used to facilitate fusion and supplemental internal spinal fixation. This aligns with the definition of a therapeutic device as it is intended to treat a medical condition.
No
The NuVasive CoRoent Thoracolumbar System is an implantable device used for spinal fusion, not for diagnosing medical conditions. It is a therapeutic device designed to facilitate fusion and provide internal spinal fixation.
No
The device description explicitly states the system consists of physical implants made from titanium alloy and PEEK, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The NuVasive CoRoent Thoracolumbar System is a physical implant made of titanium alloy and PEEK. It is surgically placed into the spine to facilitate fusion.
- Intended Use: The intended use is for intervertebral body fusion of the spine in skeletally mature patients with specific spinal conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant used in the treatment of spinal conditions, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Nu Vasive® CoRoent® Thoracolumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and or allogeneic bone graft comprised of cancellous and or corticocancellous bone graft to facilitate fusion and supplemental internal spinal 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 nonoperative treatment.
The NuVasive CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the CoRoent Thoracolumbar System (XL and L platforms) implants 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 hemiation (with mvelopathy and or radiculopathy without axial pain). DDD is defined as back pain of discogence origin with degeneration of the disc confirmed by history and radiographic studies.
The Nu Vasive CoRoent Thoracolumbar System (XL and L platforms) can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Product codes
MAX, PHM
Device Description
The subject NuVasive CoRoent Thoracolumbar System consists of devices manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3, and PEEK Optima LT-1 with titanium alloy or tantalum pins conforming to ASTM F136 or ASTM F1472 (tantalum markers conforming to ASTM 560 or ISO 13782). The implants are hollow devices with teeth on the endplate surfaces. The hollow core allows for the packing of autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to help promote a solid fusion. Small teeth on each end of the device serve to grip the adjacent vertebrae to resist migration of the device. The varying footprints are designed to address individual pathology and anatomic conditions of the patient, utilizing placement through various surgical approaches. The device is intended to be used with supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The subject implants are offered sterile and non-sterile with the accessory surgical instruments packaged as non-sterile to be sterilized by the end user.
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
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)
Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. The previously presented mechanical testing data are sufficient to support the addition of the titanium alloy implants to the subject system and does not warrant the need for additional nonclinical testing. Therefore, no new mechanical testing was performed for this 510(k) submission. Additionally, an engineering rationale was provided for MR compatibility for subject devices.
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NuVasive, Incorporated Marysa Loustalot Sr. Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
June 26, 2017
Re: K170962
Trade/Device Name: NuVasive® CoRoent® Thoracolumbar System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: March 30, 2017 Received: March 31, 2017
Dear Marysa Loustalot:
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-
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "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.
1
related 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.
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) 170962
Device Name
NuVasive® CoRoent® Thoracolumbar System
Indications for Use (Describe)
The Nu Vasive® CoRoent® Thoracolumbar System is indicated for intervertebral body fusion of the spine in sketally mature patients. The System is designed for use with autogenous and or allogeneic bone graft comprised of cancellous and or corticocancellous bone graft to facilitate fusion and supplemental internal spinal 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 nonoperative treatment.
The NuVasive CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the CoRoent Thoracolumbar System (XL and L platforms) implants 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 hemiation (with mvelopathy and or radiculopathy without axial pain). DDD is defined as back pain of discogence origin with degeneration of the disc confirmed by history and radiographic studies.
The Nu Vasive CoRoent Thoracolumbar System (XL and L platforms) can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
| 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. The leaf shape is on the left side of the logo, and the word "NUVASIVE" is on the right side.
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
Marysa Loustalot Sr. Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: June 22, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® CoRoent® Thoracolumbar System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3080 |
MAX, PHM
Product Code:
C.
Predicate Devices The subject NuVasive CoRoent Thoracolumbar System is substantially equivalent to the primary predicate device, NuVasive Lumbar Interbody Implants (K161230), and additional predicates NuVasive CoRoent Thoracolumbar System (K153419) and NuVasive CoRoent Titanium System (K120918).
D. Device Description
The subject NuVasive CoRoent Thoracolumbar System consists of devices manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3, and PEEK Optima LT-1 with titanium alloy or tantalum pins conforming to ASTM F136 or ASTM F1472 (tantalum markers conforming to ASTM 560 or ISO 13782). The implants are hollow devices with teeth on the endplate surfaces. The hollow core allows for the packing of autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to help promote a solid fusion. Small teeth on each end of the device serve to grip the adjacent vertebrae to resist migration of the device. The varying footprints are designed to address individual pathology and anatomic conditions of the patient, utilizing placement through various surgical approaches. The device is intended to be used with supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The subject implants are offered sterile and non-sterile with the accessory surgical instruments packaged as non-sterile to be sterilized by the end user.
4
The purpose of this 510(k) submission is to introduce titanium versions of the PEEK devices cleared in K161230 and add MR Conditional labeling.
E. Indications for Use
The NuVasive CoRoent Thoracolumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal 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 NuVasive CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the CoRoent Thoracolumbar System (XL and L platforms) implants 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 NuVasive CoRoent Thoracolumbar System (XL and L platforms) can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
F. Technological Characteristics
As was established in this submission, the subject NuVasive CoRoent Thoracolumbar 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
Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. The previously presented mechanical testing data are sufficient to support the addition of the titanium alloy implants to the subject system and does not warrant the need for additional nonclinical testing. Therefore, no new mechanical testing was performed for this 510(k) submission.
Additionally, an engineering rationale was provided for MR compatibility for subject devices.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject NuVasive CoRoent Thoracolumbar System has been shown to be substantially equivalent to legally marketed predicate devices.