(101 days)
Not Found
No
The 510(k) summary describes a physical spinal implant made of PEEK or titanium, with no mention of software, algorithms, or any technology related to AI or ML. The focus is on the material, design, and intended use for spinal fusion.
Yes
The device is indicated for intervertebral body fusion of the spine for the treatment of degenerative disc disease and degenerative scoliosis, which are medical conditions, and is designed to facilitate fusion and provide stabilization.
No
This device is described as an intervertebral body fusion implant for the spine, used to facilitate fusion and provide supplemental fixation. It is a therapeutic device, not one designed to diagnose conditions.
No
The device description explicitly states the device is manufactured from PEEK or titanium alloy and includes physical implants with radiographic markers and teeth, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The NuVasive CoRoent Lumbar System is a surgical implant designed for intervertebral body fusion in the spine. It is a physical device implanted into the body to treat a structural issue (degenerative disc disease and degenerative scoliosis).
- Lack of Specimen Handling: The description does not mention any interaction with human specimens for diagnostic purposes.
Therefore, based on the provided information, the NuVasive CoRoent Lumbar System is a surgical implant, not an In Vitro Diagnostic device.
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 implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbar spine. 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) are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-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. Additionally, the CoRoent Lumbar System (L and XL platforms) can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Product codes
MAX
Device Description
The CoRoent Lumbar System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK device contains radiographic markers manufactured from titanium alloy conforming to ASTM F136 or ASTM F1472. The implants are available in a variety of different shapes and sizes 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. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. The purpose of this 510(k) is to expand the indications for use of previously cleared CoRoent Lumbar implants for use in patients with degenerative scoliosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, from L1-L2 to L5-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)
No performance data was provided to demonstrate that the subject NuVasive CoRoent Lumbar System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NuVasive CoRoent System (K141896), NuVasive CoRoent System (K141665)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
NuVasive, Incorporated Martin A. Yahiro, M.D. Director, Medical Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K151472
Trade/Device Name: NuVasive® CoRoent® Lumbar Sytem Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 15, 2015 Received: June 16, 2015
Dear Dr. Yahiro:
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
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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K151472 |
|---|---|
| Device Name | NuVasive® CoRoent® Lumbar System |
| Indications for Use (Describe) | The NuVasive CoRoent Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature |
| patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal | |
| spinal fixation system cleared by the FDA for use in the lumbar spine. 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) are intended for use at either one level or two contiguous levels in the | |
| lumbar spine, from L1-L2 to L5-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. Additionally, the CoRoent Lumbar System (L and XL platforms) can be used as an adjunct to | |
| fusion in patients diagnosed with 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) |
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
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PSC Publishing Services (301) 443-6740 EF
r and states of the state of the comment of the comment of the
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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller, lighter font.
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:
Martin Yahiro, M.D. Director, Medical Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: September 4, 2015
B. Device Name
| Trade or Proprietary Name: | NuVasive® CoRoent® Lumbar 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: | MAX |
C. Predicate Devices
The subject NuVasive CoRoent Lumbar System is substantially equivalent to the primary predicate device, NuVasive CoRoent System (K141896) and additional predicate NuVasive CoRoent System (K141665).
D. Device Description
The CoRoent Lumbar System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK device contains radiographic markers manufactured from titanium alloy conforming to ASTM F136 or ASTM F1472. The implants are available in a variety of different shapes and sizes 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. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. The purpose of this 510(k) is to expand the indications for use of previously cleared CoRoent Lumbar implants for use in patients with degenerative scoliosis.
E. Indications for Use
The NuVasive® CoRoent Lumbar System is indicated for the following:
The NuVasive CoRoent Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
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Image /page/4/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 simple and modern, and the colors are eye-catching.
The CoRoent Lumbar System (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-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. Additionally, the CoRoent Lumbar System (L and XL platforms) can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Technological Characteristics F.
As was established in this submission, the subject NuVasive CoRoent Lumbar System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. There have been no design changes to the implants previously cleared in the predicate 510(k)s. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
G. Performance Data
No performance data was provided to demonstrate that the subject NuVasive CoRoent Lumbar System is substantially equivalent to the predicate devices.
H. Conclusions
Based on the technological characteristics and comparison to predicate devices, the subject NuVasive CoRoent Lumbar System has been shown to be substantially equivalent to legally marketed predicate devices.