(119 days)
Not Found
No
The summary describes a physical interbody fusion device made of titanium alloy with specific structural features. There is no mention of software, algorithms, image processing, AI, ML, or data analysis related to patient diagnosis, treatment planning, or device performance prediction. The testing described is entirely non-clinical and focused on the mechanical and material properties of the implant.
Yes.
The device is an interbody implant indicated for intervertebral body fusion of the spine to treat conditions like symptomatic disc degeneration and degenerative spondylolisthesis, aiming to relieve symptoms and restore function.
No
The device is an interbody implant designed for spinal fusion, a treatment rather than a diagnostic procedure.
No
The device description clearly states it is an interbody implant manufactured from titanium alloy, which is a physical hardware component. The performance studies also focus on the mechanical properties of the implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intervertebral body fusion of the spine" and is used in surgical procedures to treat conditions like symptomatic disc degeneration and degenerative spondylolisthesis. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium alloy designed to be placed in the spine. It describes its structure, materials, and how it interacts with bone and other fixation systems. This is consistent with a surgical implant, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies focus on the mechanical properties and safety of the implant (e.g., compression, shear, abrasion, push-out, subsidence), which are relevant to a surgical device, not a diagnostic one.
In summary, the NuVasive Modulus XLIF Interbody System is a surgical implant used for spinal fusion, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NuVasive Modulus XLIF 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 and 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 nonoperative treatment.
The NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and 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 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 XLIF Interbody System is also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.
Product codes
MAX, PHM
Device Description
The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from 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 thoracolumbar spine.
The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intervertebral body fusion of the spine, thoracolumbar spine from T1 to T12 and at the 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)
Non-clinical testing was performed to demonstrate that the subject NuVasive Modulus XLIF 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)
- Taber Abrasion (per ASTM F1978)
- Push-out (per ASTM F04-25-02-02 Draft)
- Subsidence (per ASTM F2267)
- Stereological Evaluation of Porous Coatings (per ASTM F1854)
- Metallurgical analysis per ASTM E1097, E1409, E1941 and E112
- Tension testing (per ASTM E8/E8M)
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016.
The results demonstrate that the subject NuVasive Modulus XLIF 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)
K161230, K150481, K152304, K141665, K140319
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2017
NuVasive, Incorporated Cynthia Adams Regulatory Affairs Specialist 7475 Lusk Blvd. San Diego, California 92121
Re: K163230
Trade/Device Name: NuVasive® Modulus XLIF Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, PHM Dated: February 10, 2017 Received: February 13, 2016
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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/ResourcesforYou/Industry/default.htm. 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.
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,
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.
Page 1 of 1
510(k) Number (if known)
Device Name NuVasive® Modulus XLIF Interbody System
Indications for Use (Describe)
The NuVasive Modulus XLIF 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 and 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 nonoperative treatment.
The NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and 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 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 XLIF Interbody System is also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.
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 on the left, followed by the word "NUVASIVE" in gray. The leaf shape is divided into two sections, with the top section in purple and the bottom section 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:
Submitted by: A.
Cynthia Adams Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: March 14, 2017
Device Name B.
| Trade or Proprietary Name: | NuVasive® Modulus 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 |
C. Predicate Devices
The subject NuVasive Modulus XLIF Interbody System is substantially equivalent to the primary predicate device CoRoent® Lumbar Interbody Implants cleared in 510(k) K161230. Additional predicates include K2M CASCADIA™ Interbody System (K150481), Stryker Spine Tritanium PL® Cage (K152304), CoRoent System (K141665), CoRoent Ti-C System (K140319) and CoRoent Ti-C System (K140319).
D. Device Description
The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from 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 thoracolumbar spine.
The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
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Image /page/4/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is divided into two parts, with the top part in purple and the bottom part in gray.
E. Indications for Use
The NuVasive Modulus XLIF 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 and 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 XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and 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 Modulus XLIF Interbody System is also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.
F. Technological Characteristics
As was established in this submission, the subject NuVasive Modulus 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
Non-clinical testing was performed to demonstrate that the subject NuVasive Modulus XLIF 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)
- . . . Taber Abrasion (per ASTM F1978)
- Push-out (per ASTM F04-25-02-02 Draft)
- . Subsidence (per ASTM F2267)
- . Stereological Evaluation of Porous Coatings (per ASTM F1854)
- Metallurgical analysis per ASTM E1097, E1409, E1941 and E112 .
- Tension testing (per ASTM E8/E8M) ●
- 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 Nuvasive logo. 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.
The results demonstrate that the subject NuVasive Modulus XLIF 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.
Conclusions H.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject NuVasive Modulus XLIF Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.