(100 days)
Not Found
No
The 510(k) summary describes a physical interbody fusion device made of titanium alloy. There is no mention of software, algorithms, or any AI/ML related terms or functionalities. The performance studies are based on mechanical testing of the implant.
Yes
The device is an interbody fusion system designed to treat cervical disc degeneration and spinal instability, promoting intervertebral body fusion. This directly addresses medical conditions to restore physiological function.
No
This device is an intervertebral body implant used for spinal fusion, not for diagnosing conditions. It is used to treat conditions confirmed by imaging studies, not to perform the diagnosis itself.
No
The device description explicitly states the device is an interbody implant manufactured from titanium alloy, which is a physical hardware component.
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 (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The NuVasive Modulus-C Interbody System is an implantable device designed to be surgically placed in the spine to facilitate fusion. It is a physical device used in the body, not a device used to test samples from the body.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any other activities typical of an IVD. The performance studies focus on the mechanical properties and biocompatibility of the implant.
N/A
Intended Use / Indications for Use
The NuVasive Modulus-C Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Modulus-C Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.
Product codes
ODP
Device Description
The subject NuVasive Modulus-C Interbody System are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration and expulsion of the device. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervicothoracic spine. The implants are available in a variety sizes and lordotic angles 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
radiographs, CT, MRI
Anatomical Site
cervical spine, C2 - T1
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)
Non-clinical testing was performed to demonstrate that the subject NuVasive Modulus-C Interbody System is substantially equivalent to other predicate devices. The following testing was performed:
- Static Compression (per ASTM F2077)
- Dynamic Compression (per ASTM F2077)
- Static Compression Shear (per ASTM F2077)
- Dynamic Compression Shear (per ASTM F2077)
- Gravimetric and Particulate analysis (ASTM F1714 and F1877)
- Push-out (per ASTM F04-25-02-02 Draft)
- Subsidence (per ASTM F2267)
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results demonstrate that the subject NuVasive Modulus-C Interbody 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K163491, K163230, K140003, K081611, K162138, K120603
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NuVasive, Incorporated Cynthia Adams Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
December 14, 2017
Re: K172676
Trade/Device Name: NuVasive® Modulus-C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: November 13, 2017 Received: November 14, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172676
Device Name
NuVasive® Modulus-C Interbody System
Indications for Use (Describe)
The NuVasive Modulus-C Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Modulus-C Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.
| 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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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 sans-serif font. The logo is clean and modern, with a focus on the company name.
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 Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: November 9, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® Modulus-C Interbody 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: | ODP |
C. Predicate Devices
The subject NuVasive Modulus-C Interbody System is substantially equivalent to the primary predicate device NuVasive CoRoent® Small Interbody System cleared in K163491. Additional predicates include NuVasive Modulus XLIF Interbody System (K163230), CoRoent Small Interbody System (K140003), NuVasive CoRoent System (K081611), NuVasive CoRoent Small Ti-C System (K162138) and VariLifi® Cervical Interbody Fusion Device (K120603).
Device Description D.
The subject NuVasive Modulus-C Interbody System are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration and expulsion of the device. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervicothoracic spine. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient.
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Image /page/4/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray. The word "NUVASIVE" is in a sans-serif font.
Nu Vasive® Modulus-C Interbody System
E. Indications for Use
The NuVasive Modulus-C Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Modulus-C Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.
F. Technological Characteristics
As was established in this submission, the subject NuVasive Modulus-C 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
Non-clinical testing was performed to demonstrate that the subject NuVasive Modulus-C Interbody System is substantially equivalent to other predicate devices. The following testing was performed:
- Static Compression (per ASTM F2077) ●
- Dynamic Compression (per ASTM F2077) ●
- Static Compression Shear (per ASTM F2077)
- Dynamic Compression Shear (per ASTM F2077)
- Gravimetric and Particulate analysis (ASTM F1714 and F1877)
- Push-out (per ASTM F04-25-02-02 Draft)
- Subsidence (per ASTM F2267)
- o Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results demonstrate that the subject NuVasive Modulus-C Interbody 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 NuVasive Modulus-C Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.