(264 days)
Not Found
No
The summary describes a physical implant device and its mechanical and clinical performance, with no mention of AI, ML, or related computational analysis.
Yes
The device is a vertebral body replacement system used to treat diseased or damaged vertebral bodies, reconstruct the spine, and decompress the spinal cord, all of which aim to restore function and alleviate conditions, fitting the definition of a therapeutic device.
No
This device is a vertebral body replacement system used for surgical reconstruction and stabilization of the cervical spine, not for diagnosing medical conditions.
No
The device description explicitly states it is a vertebral body replacement system manufactured from PEEK and contains titanium or tantalum pins, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The NuVasive Monolith Cervical Corpectomy System is a physical implant designed to replace a diseased or damaged vertebral body in the cervical spine. It is surgically implanted into the patient's body.
- Lack of Diagnostic Activity: The device does not perform any tests on biological samples to diagnose a condition. Its function is structural and reconstructive.
Therefore, the NuVasive Monolith Cervical Corpectomy System falls under the category of a medical device, specifically a surgical implant, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® Monolith Cervical Corpectomy System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive® Monolith Cervical Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes
PLR
Device Description
The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The Monolith Cervical Corpectomy System is made up of two primary components: a core and a set of endcaps. The core is offered in a variety of shapes and sizes to suit individual pathology and anatomical conditions of the patient. The modular standard and railed endcaps are offered in multiple footprints and lordosis options.
The device contains pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 to serve as radiopaque markers. The system is provided non-sterile, and is designed to be sterilized by the user before each use.
The purpose of this 510(k) is to expand the indications for use of NuVasive Monolith Corpectomy System (K170271) to include the treatment of tumors, trauma, and degenerative disorders of the cervical spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-C7 vertebral bodies)
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
Mechanical performance testing data was provided as part of previous submissions to establish substantial equivalence for its use as a vertebral body replacement in the throacolumbar spine: worst case devices included with the subject system were tested and cleared in these predicate 510(k) submissions. Additional dynamic compression and dynamic torsion testing per ASTM F2077 was performed for the subject device. The proposed expansion of the indications for use to include their use in the treatment of tumors, trauma, degenerative disorders, and osteomyelitis of the cervical spine does not create a new mechanical worst-case for any of the implants. Since no new device designs and no new worst case sizes are being introduced to the subject NuVasive Monolith Cervical Corpectomy System, the previously presented mechanical testing data along with additional dynamic testing data are sufficient to support the proposed expanded indications for use.
A retrospective clinical study was performed on patients with cervical degenerative disorders, tumor, fracture, and osteomyelitis treated with the subject device. Based on the clinical data, it was determined that the NuVasive Monolith Cervical Corpectomy System used in the treatment of cervical degenerative disorders, tumor, fracture, and osteomyelitis has a safety and effectiveness profile similar to the predicate device. Additionally, a clinical literature analysis of cervical corpectomy procedures was performed to support the use of the subject device.
The subject NuVasive Monolith Cervical Corpectomy System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
NuVasive X-Core® Mini Cervical Expandable VBR System (K151651), Monolith Corpectomy System (K170271), NuVasive CoRoent System (K081611)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 20, 2018
NuVasive, Incorporated Olga Lewis Senior Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K180550
Trade/Device Name: NuVasive® Monolith™ Cervical Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR Dated: October 18, 2018 Received: October 19, 2018
Dear Ms. 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
Melissa Hall -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
510(k) Number (if known) K180550
Device Name
NuVasive® Monolith™ Cervical Corpectomy System
Indications for Use (Describe)
The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® Monolith Cervical Corpectomy System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive® Monolith Cervical Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
| 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/1 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, and there is a trademark symbol after the word.
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 Senior Manger, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360
Date Prepared: October 18, 2018
B. Device Name
| Trade or Proprietary Name: | NuVasive® Monolith™ Cervical Corpectomy System |
|---|---|
| Common or Usual Name: | Spinal Vertebral Body Replacement Device |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3060 |
| Product Code: | PLR |
C. Predicate Devices
The subject Monolith Cervical Corpectomy System is substantially equivalent to a primary predicate device, NuVasive X-Core® Mini Cervical Expandable VBR System (K151651), and additional predicate devices, Monolith Corpectomy System (K170271) and NuVasive CoRoent System (K081611).
D. Device Description
The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The Monolith Cervical Corpectomy System is made up of two primary components: a core and a set of endcaps. The core is offered in a variety of shapes and sizes to suit individual pathology and anatomical conditions of the patient. The modular standard and railed endcaps are offered in multiple footprints and lordosis options.
The device contains pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 to serve as radiopaque markers. The system is provided non-sterile, and is designed to be sterilized by the user before each use.
The purpose of this 510(k) is to expand the indications for use of NuVasive Monolith Corpectomy System (K170271) to include the treatment of tumors, trauma, and degenerative disorders of the cervical spine.
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Image /page/4/Picture/1 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 split into two halves, with the top half in purple and the bottom half in gray.
E. Indications For Use
The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive Monolith Cervical Corpectomy System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive Monolith Cervical Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
F. Technological Characteristics
The subject Monolith Cervical Corpectomy 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 have equivalent 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
Mechanical performance testing data was provided as part of previous submissions to establish substantial equivalence for its use as a vertebral body replacement in the throacolumbar spine: worst case devices included with the subject system were tested and cleared in these predicate 510(k) submissions. Additional dynamic compression and dynamic torsion testing per ASTM F2077 was performed for the subject device. The proposed expansion of the indications for use to include their use in the treatment of tumors, trauma, degenerative disorders, and osteomyelitis of the cervical spine does not create a new mechanical worst-case for any of the implants. Since no new device designs and no new worst case sizes are being introduced to the subject NuVasive Monolith Cervical Corpectomy System, the previously presented mechanical testing data along with additional dynamic testing data are sufficient to support the proposed expanded indications for use.
A retrospective clinical study was performed on patients with cervical degenerative disorders, tumor, fracture, and osteomyelitis treated with the subject device. Based on the clinical data, it was determined that the NuVasive Monolith Cervical Corpectomy System used in the treatment of cervical degenerative disorders, tumor, fracture, and osteomyelitis has a safety and effectiveness profile similar to the predicate device. Additionally, a clinical literature analysis of cervical corpectomy procedures was performed to support the use of the subject device.
The subject NuVasive Monolith Cervical Corpectomy System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate.
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Image /page/5/Picture/1 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 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.
No changes to the subject device have been made since the clearance in K170271. Comparison to the predicate devices was provided to support substantial equivalence.
H. Conclusions
Based on the indications for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject Monolith Cervical Corpectomy System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.