(118 days)
Not Found
No
The summary describes a physical interbody fusion device made of titanium and MP35N, with no mention of software, algorithms, or AI/ML terms. The performance studies are based on mechanical testing, not data analysis or image processing.
Yes.
The device is indicated for intervertebral body fusion of the spine for the treatment of symptomatic disc degeneration or degenerative spondylolisthesis, which aims to treat or alleviate a disease, thus classifying it as a therapeutic device.
No
The device is an intervertebral fusion device intended for use in spinal fusion surgeries, which is a treatment, not a diagnostic process.
No
The device description explicitly states the device is manufactured from titanium alloy and nickel-cobalt-chromium-molybdenum, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes tests performed on blood, urine, tissues, etc.
- Device Description and Intended Use: The NuVasive TLX Interbody System is a surgical implant designed for intervertebral body fusion of the spine. It is a physical device implanted into the body to provide structural support and facilitate bone fusion.
- Lack of IVD Characteristics: The description does not mention any testing of biological specimens, analysis of bodily fluids or tissues, or providing diagnostic information based on such analysis.
Therefore, the NuVasive TLX Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive TLX 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 TLX 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 TLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Product codes
MAX, PHM
Device Description
The TLX Interbody intervertebral fusion device is designed to address lumbar pathologies utilizing interbody placement through a standard posterolateral approach. The NWasive TLX Interbody System is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3, and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes 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
Not Found
Anatomical Site
thoracolumbar spine, thoracic 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
Nonclinical testing was performed to demonstrate that the subject TLX Interbody System is substantially equivalent to other predicate devices. The following testing was performed: Static and dynamic axial compression and compression shear testing per ASTM F2077; Static push-out testing per ASTM draft standard F-04.25.02.02 (work item Z8423Z); Subsidence analysis. The results demonstrate that the subject TLX Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
K170962, K153627, K141665, K071795, K161230, K140770
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/2 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 symbol of three human profiles facing to the right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NuVasive, Incorporated Cynthia Adams Senior Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
September 28, 2017
Re: K171633
Trade/Device Name: NuVasive® TLX Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, PHM Dated: September 1, 2017 Received: September 5, 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 (reporting of medical device
1
related 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.
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 (DICE) 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 (DICE) 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,
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) K171633
Device Name
NuVasive® TLX Interbody System
Indications for Use (Describe)
The NuVasive TLX 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 TLX 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 TLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel 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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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller, italicized 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:
Cynthia Adams Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: September 1, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® TLX 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 TLX Interbody System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Thoracolumbar System (K170962) serves as the primary predicate device, while NuVasive TLX Interbody System (K153627), NuVasive CoRoent® System (K141665), NuVasive CoRoent System (K071795), NuVasive Lumbar Interbody Implants (K161230), and NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System (K140770) are additional predicate devices.
D. Device Description
The TLX Interbody intervertebral fusion device is designed to address lumbar pathologies utilizing interbody placement through a standard posterolateral approach. The NWasive TLX Interbody System is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3, and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
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Image /page/4/Picture/1 description: The image contains the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with a horizontal line extending from the left side of the phrase.
Indications for Use E.
The NuVasive TLX 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 TLX 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 TLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
F. Technological Characteristics
As was established in this submission, the subject TLX 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.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject TLX Interbody System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear testing per ASTM F2077
- Static push-out testing per ASTM draft standard F-04.25.02.02 (work item Z8423Z) ●
- Subsidence analysis ●
The results demonstrate that the subject TLX Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject TLX Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.