(88 days)
Not Found
No
The 510(k) summary describes a mechanical vertebral body replacement device made of PEEK and titanium/tantalum. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is a partial or total vertebral body replacement device, which is used to treat diseased or damaged vertebral bodies and restore height, fitting the description of a therapeutic device.
No
This device is a vertebral body replacement system, not a device used to diagnose medical conditions. Its purpose is to treat diseased or damaged vertebral bodies by replacing them.
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:
- Intended Use: The intended use clearly describes a device that is surgically implanted to replace a vertebral body. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of an implantable device (core, endcaps, pins) made from materials suitable for implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing information for diagnosis. The device's function is structural support and replacement.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment decisions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Nuvasive® PEEK Corpectomy Railed System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The PEEK Corpectomy Railed System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.
Product codes
MQP
Device Description
The NuVasive PEEK Corpectomy Railed System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The PEEK Corpectomy Railed 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to L5)
Indicated Patient Age Range
Not Found
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 PEEK Corpectomy Railed System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic torsion per ASTM F2077 ●
- Push-out testing ●
- Subsidance analysis
The results demonstrate that the subject PEEK Corpectomy Railed System is substantially equivalent to predicate devices. No non-clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
K032476, K142205, K012254, K070173, K050553
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2015
NuVasive, Incorporated Ms. Olga Lewis Lead Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K151538
Trade/Device Name: NuVasive® PEEK Corpectomy Railed System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 4, 2015 Received: August 7, 2015
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. 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Olga Lewis
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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Mark N. Melkerson -S
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) K151538
Device Name
NuVasive® PEEK Corpectomy Railed System
Indications for Use (Describe)
The Nuvasive® PEEK Corpectomy Railed System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The PEEK Corpectomy Railed System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.
Type of Use (Select one or both, as applicable)
2 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 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 purple gradient effect.
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 Lead Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360
Date Prepared: August 4, 2015
B. Device Name
| Trade or Proprietary Name: | NuVasive® PEEK Corpectomy Railed 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: | MQP |
C. Predicate Devices
The subject PEEK Corpectomy Railed System is substantially equivalent to a primary predicate device, NuVasive Mesh (K032476), and additional predicate devices, NuVasive X-Core Expandable VBR System (K142205), Osteotech VBR (K012254), Medtronic Verte-Stack® Spinal System (K070173), and Novel VBR Spinal System (K050553).
D. Device Description
The NuVasive PEEK Corpectomy Railed System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The PEEK Corpectomy Railed 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 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.
E. Indications For Use
The Nuvasive® PEEK Corpectomy Railed System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The PEEK Corpectomy Railed System is intended to be used with supplemental internal
4
spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
F. Technological Characteristics
The subject PEEK Corpectomy Railed 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
Nonclinical testing was performed to demonstrate that the subject PEEK Corpectomy Railed System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic torsion per ASTM F2077 ●
- Push-out testing ●
- Subsidance analysis
The results demonstrate that the subject PEEK Corpectomy Railed System is substantially equivalent to predicate devices. No non-clinical studies were conducted.
H. Conclusions
Based on the indications for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject PEEK Corpectomy Railed System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.