(89 days)
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies are focused on mechanical and material properties.
Yes.
The device is specifically designed for intervertebral body fusion of the spine, treating conditions such as symptomatic disc degeneration and degenerative spondylolisthesis, which aims to alleviate symptoms for patients.
No
Explanation: The device is an expandable interbody system designed for intervertebral body fusion of the spine, which is a therapeutic treatment. It is not described as being used to diagnose a medical condition.
No
The device description explicitly states it is an expandable interbody system additively manufactured from titanium alloy and nickel-cobalt-chromium-molybdenum, which are hardware components. The performance studies also focus on mechanical testing of the physical implant.
Based on the provided information, 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 MOD-EX XLIF Interbody System is a surgical implant designed to be placed within the body to facilitate spinal fusion. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the NuVasive MOD-EX XLIF Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive MOD-EX XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. When used with or without the MOD-EX XLIF internal fixation, the system is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. When ≥20° lordosis is needed, the plated MOD-EX XLIF interbody must be used along with additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.
The MOD-EX XLIF Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is 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 thoracy 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 MOD-EX XLIF Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis and sagittal deformity.
Product codes
MAX, PHM, OVD
Device Description
The NuVasive MOD-EX XLIF Interbody System is an expandable interbody system additively manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C and traditionally manufactured from both titanium alloy (Ti-6V-4A1 ELI) per ASTM F136 or ISO 5832-3 and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. MOD-EX XLIF interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The device features independent threaded drive and wedge mechanisms to allow for independent expansion of the anterior and posterior aspect of the implant. The superior and inferior endplate components are solid and porous structures manufactured simultaneously using a powder bed fusion method. The microporous, textured surfaces on the superior and inferior ends of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX XLIF Interbody System interbodies have superior and inferior graft apertures, allowing for packaging of graft to aid in the promotion of a solid fusion.
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 is intended for use in 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)
Nonclinical testing was performed to demonstrate that the subject MOD-EX XLIF Interbody System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression testing per ASTM F2077
- Static and dynamic compression-shear testing per ASTM F2077
- Dynamic torsion testing per ASTM F2077
- Gravimetric and Particulate analysis (ASTM F1714 and F1877)
- Screw push-out analysis
- Subsidence analysis
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results demonstrate that the subject MOD-EX XLIF Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NuVasive Modulus XLIF Interbody System (K201820), NuVasive XLX Interbody System (K173892), NuVasive Lumbar Interbody Implants (K161230), NuVasive Cohere Thoracolumbar Interbody System (K181860), NuVasive Modulus XLIF Interbody System (K163230)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 12, 2021
NuVasive, Incorporated Manthan Damani Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
Re: K210439
Trade/Device Name: NuVasive® MOD-EX XLIF Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM, OVD Dated: May 7, 2021 Received: May 10, 2021
Dear Manthan Damani:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K210439
Device Name NuVasive® MOD-EX XLIF Interbody System
Indications for Use (Describe)
The NuVasive MOD-EX XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. When used with or without the MOD-EX XLIF internal fixation, the system is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. When ≥20° lordosis is needed, the plated MOD-EX XLIF interbody must be used along with additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.
The MOD-EX XLIF Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is 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 thoracy 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 MOD-EX XLIF Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis and sagittal deformity.
| 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 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.
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:
Manthan J. Damani Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 458-2272
Date Prepared: February 11, 2021
B. Device Name
| Trade or Proprietary Name: | NuVasive® MOD-EX XLIF 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: | MAX, PHM, OVD |
C. Predicate Devices
The subject NuVasive MOD-EX XLIF Interbody System is substantially equivalent to multiple predicate devices. NuVasive Modulus XLIF Interbody System (K201820) serves as the primary predicate device, while NuVasive XLX Interbody System (K173892), NuVasive Lumbar Interbody Implants (K161230), NuVasive Cohere Thoracolumbar Interbody System (K181860) and NuVasive Modulus XLIF Interbody System (K163230) are additional predicate devices.
D. Device Description
The NuVasive MOD-EX XLIF Interbody System is an expandable interbody system additively manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C and traditionally manufactured from both titanium alloy (Ti-6V-4A1 ELI) per ASTM F136 or ISO 5832-3 and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. MOD-EX XLIF interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The device features independent threaded drive and wedge mechanisms to allow for independent expansion of the anterior and posterior aspect of the implant. The superior and inferior endplate components are solid and porous structures manufactured simultaneously using a powder bed fusion method. The microporous, textured surfaces on the superior and inferior ends of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX XLIF Interbody System
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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 sans-serif font. The leaf shape is on the left side of the logo, and the word "NUVASIVE" is on the right side.
interbodies have superior and inferior graft apertures, allowing for packaging of graft to aid in the promotion of a solid fusion.
E. Indications for Use
The NuVasive MOD-EX XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. When used with or without the MOD-EX XLIF internal fixation, the system is intended 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. When ≥20° lordosis is needed, the plated MOD-EX XLIF interbody must be used along with additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.
The MOD-EX XLIF Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is 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 MOD-EX XLIF Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
F. Technological Characteristics
As was established in this submission, the subject MOD-EX XLIF 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
Nonclinical testing was performed to demonstrate that the subject MOD-EX XLIF Interbody System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression testing per ASTM F2077 ●
- Static and dynamic compression-shear testing per ASTM F2077 ●
- Dynamic torsion testing per ASTM F2077 ●
- Gravimetric and Particulate analysis (ASTM F1714 and F1877)
- Screw push-out analysis ●
- Subsidence analysis
- . Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
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Image /page/5/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 leaf shape is split into two halves, with the left half in purple and the right half in gray.
The results demonstrate that the subject MOD-EX XLIF Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate devices.
Conclusions H.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject MOD-EX XLIF Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.