(117 days)
Not Found
No
The description focuses on the mechanical design, materials, and intended use of a spinal implant and associated instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a medical implant intended to facilitate intervertebral body fusion of the spine for the treatment of symptomatic degenerative disc disease or degenerative spondylolisthesis, which are conditions directly affecting the patient's health.
No.
The device is an interbody fusion system designed for surgical implantation to facilitate spinal fusion, not to diagnose a condition.
No
The device description explicitly states it is a "thoracolumbar interbody system consisting of an interbody fusion device and associated general instruments" and is manufactured from physical materials like titanium alloy and PEEK. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is designed to be placed within the body to facilitate bone growth and stabilize the spine.
- Device Description: The device description details the physical components of the implant and its materials, all of which are related to its function as a surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is an implantable surgical device.
N/A
Intended Use / Indications for Use
The Nu Vasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody 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. The System is designed for use with 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 Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System is 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 degenerative disc disease (DDD) or degenerative spondylolistolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy 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 Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
Product codes
MAX
Device Description
The subject Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System is a thoracolumbar interbody system consisting of an interbody fusion device and associated general instruments. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a posterior (PLIF) or transforaminal (TLIF) 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 Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System interbodies are multi-component devices manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136, Invibio PEEK Optima LT-1 per ASTM F2026, and Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C. 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 endplates of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX PL 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
Spine, thoracic spine from T1 to T12, thoracolumbar junction (T12-L1), 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 NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL 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)
- Subsidence and static push-out
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results demonstrate that the subject NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K201820, K102293, K192115, K163364, K141665, 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.
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 24, 2021
NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
Re: K210214
Trade/Device Name: NuVasive® Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 21, 2021 Received: April 22, 2021
Dear Olga Lewis:
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 L. 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)
Device Name
NuVasive® Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
Indications for Use (Describe)
The Nu Vasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody 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. The System is designed for use with 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 Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System is 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 degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy 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 Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis 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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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:
Olga Lewis Director, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3302
Date Prepared: January 26, 2021
B. Device Name
| Trade or Proprietary Name: | NuVasive® Modulus Expandable Posterior Lumbar |
|---|---|
| MOD-EX PL 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 |
C. Predicate Devices
The subject NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System is substantially equivalent to the primary predicate device NuVasive Modulus TLIF Interbody System cleared in 510(k) K201820. Additional predicates include: Globus Caliber Spacer System (K102293), Globus SABLE Expandable Spacer (K192115), K2M MOJAVE Expandable Interbody System (K163364), NuVasive CoRoent Lumbar Interbody Implants (K141665), and NuVasive Modulus XLIF Interbody System (K163230).
D. Device Description
The subject Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System is a thoracolumbar interbody system consisting of an interbody fusion device and associated general instruments. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a posterior (PLIF) or transforaminal (TLIF) 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 Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System interbodies are multi-component devices manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136, Invibio PEEK Optima LT-1 per ASTM F2026, and Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C. 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 endplates
4
of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX PL Interbody System interbodies have superior and inferior graft apertures, allowing for packaging of graft to aid in the promotion of a solid fusion.
Indications for Use E.
The NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody 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. The System is designed for use with 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 Modulus Expandable Posterior Lumbar MOD-EX PL 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 degenerative disc disease (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 Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System 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 NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL 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 NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL 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)
- Subsidence and static push-out
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016 ●
5
The results demonstrate that the subject NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicates.
Conclusions H.
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.