(263 days)
Not Found
No
The summary describes a passive intervertebral body fusion device made of standard materials with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is indicated for intervertebral body fusion of the spine for the treatment of degenerative disc disease, which constitutes a therapeutic use.
No
Explanation: The device is an intervertebral body fusion device and is explicitly described as an implant used for treatment/fusion, not for diagnosis.
No
The device description explicitly states it is manufactured from physical materials (PEEK, Titanium, Tantalum) and includes implants and surgical instruments, indicating it is a hardware medical device.
No, 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: The NuVasive CoRoent Lumbar System is an implantable medical device designed for intervertebral body fusion of the spine. It is a physical structure made of materials like PEEK, Titanium, or Tantalum that is surgically placed in the body.
- Intended Use: The intended use is to facilitate fusion of the spine, not to perform diagnostic tests on bodily samples.
The description clearly indicates a surgical implant used for structural support and fusion within the body, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The NuVasive® CoRoent® Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent Lumbar System (L and XL platforms) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Product codes
MAX
Device Description
The NuVasive® CoRoent® System is manufactured from PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, Ti-6Al-4V ELI conforming to ASTM standard F136/1472 or Tantalum conforming to ASTM standard F560 or ISO 13782. These implants are available in a variety of shapes and configurations for PLIF/TLIF, XLIF and ALIF approaches, with heights ranging from 6 - 24 mm, widths ranging from 9 - 42 mm, lengths ranging from 20-65 mm and lordotic angles ranging from 0° - 20°, to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion.
Both the subject device and its accessory surgical instruments are packaged as non-sterile, to be sterilized by the end user. In addition, the implants are also offered in sterile packaged versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, from L2 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
Nonclinical testing was performed to demonstrate that the subject CoRoent System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear per ASTM F2077
- Finite Element Analysis
- Subsidence testing and analysis per ASTM F2267
The results demonstrate that the subject CoRoent System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
K071795, K113348, K120918, K123045, K130820, K131082, K132601, K080699, K140319, K133455, K090816, K123231
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 contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2015
NuVasive, Incorporated Mr. Jeremy Markovich Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K141665
Trade/Device Name: NuVasive® CoRoent® System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 12, 2015 Received: February 13, 2015
Dear Mr. Markovich:
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
1
Page 2 - Mr. Jeremy Markovich
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/Resourcesfor You/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 vours.
Lori A. Wiggins -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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K141665
Device Name NuVasive® CoRoent® System
Indications for Use (Describe)
The NuVasive CoRoent Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent Lumbar System (L and XL platforms) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------- |
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)
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, and the tagline "Speed of Innovation" in a smaller font below the company name. The logo is clean and modern, and the colors are muted and professional.
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.
Jeremy Markovich Associate Manager, Regulatory Affairs NuVasive, Inc. 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: February 12, 2015
B. Device Name
| Trade or Proprietary Name: | NuVasive® CoRoent® System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Lumba |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | MAX |
C. Predicate Devices
The subject CoRoent System is substantially equivalent to the primary predicate device, NuVasive CoRoent System (K071795), and the following additional predicate devices: Depuy Cougar Implant System (K113348), NuVasive CoRoent Titanium System (K120918), NuVasive Brigade Hyperlordotic System (K123045), NuVasive Expandable Lumbar Interbody System (K130820), InterForm Interbody Cage System (K131082), NuVasive CoRoent XL Sterile Implants (K132601), Alphatec Novel Spinal Spacer System (K080699), NuVasive CoRoent Ti-C System (K140319), Pioneer Surgical Technology, Inc. Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System (K133455), Stryker Spine AVS PL PEEK Spacers (K090816), and Globus Medical Inc. Caliber Spacers (K123231).
D. Device Description
The NuVasive® CoRoent System is manufactured from PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, Ti-6Al-4V ELI conforming to ASTM standard F136/1472 or Tantalum conforming to ASTM standard F560 or ISO 13782. These implants are available in a variety of shapes and configurations for PLIF/TLIF, XLIF and ALIF approaches, with heights ranging from 6 - 24 mm, widths ranging from 9 - 42 mm, lengths ranging from 20-65 mm and lordotic angles ranging from 0° - 20°, to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion.
4
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, and the words "Speed of Innovation" in a smaller font below. The logo is simple and modern, and the colors are eye-catching.
Both the subject device and its accessory surgical instruments are packaged as non-sterile, to be sterilized by the end user. In addition, the implants are also offered in sterile packaged versions.
E. Intended Use
The NuVasive CoRoent Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. The devices are to be used in patients who have had at least six months of non-operative treatment. The CoRoent Lumbar System (L and XL platforms) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
F. Technological Characteristics
As was established in this submission, the subject CoRoent System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United The subject device was shown to be substantially equivalent and have the same States. 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 System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear per ASTM F2077
- Finite Element Analysis ●
- . Subsidence testing and analysis per ASTM F2267
The results demonstrate that the subject CoRoent System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CoRoent System has been shown to be substantially equivalent to legally marketed predicate devices.