(89 days)
Not Found
No
The document describes a mechanical implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for use in spinal fusion procedures to maintain the relative position of weak bony tissue, which is a therapeutic purpose.
No
The device is an anterior non-load bearing plate system intended for use in spinal fusion procedures to maintain the relative position of weak bony tissue, not to diagnose a condition.
No
The device description explicitly states it is a plate system manufactured from various metal alloys, indicating it is a physical hardware device.
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 a "spinal fusion procedure" device used to "maintain the relative position of weak bony tissue". This describes a surgical implant used in vivo (within the body) during a medical procedure.
- Device Description: The description details the materials and types of implants, which are physical components designed to be surgically placed in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The NuVasive ALIF Buttress Plate System is an anterior non-load bearing plate system that may be used in the thoracic, lumbar and sacral spine (T1-S1). The NuVasive ALIF Buttress Plate System, in conjuction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing applications.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The NuVasive ALIF Buttress Plate System is an anterior non-load bearing plate system manufactured from Ti-6A1-4V per ASTM F1472 or Ti-6Al-4V ELI per ASTM F136, Nickel-Cobalt-Chromium-Molybdenum Alloy (Carpenter MP35NTM Alloy) per ASTM F562, and Nitinol SE510 per ASTM F2063. 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
thoracic, lumbar and sacral spine (T1-S1)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed to demonstrate the subject ALIF Buttress Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and Dynamic Cantilever Bending Testing per ASTM F1717-13
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K021039, K121837, K072339, K072943, K040130, K090415
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2015
NuVasive, Incorporated Ms. Michelle Cheung Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K143065
Trade/Device Name: NuVasive® ALIF Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 23, 2014 Received: October 24, 2014
Dear Ms. Cheung:
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
1
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 yours,
Vincent J. Devlin -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)
K143065
Device Name NuVasive® ALIF Buttress Plate System
Indications for Use (Describe)
The NuVasive ALIF Buttress Plate System is an anterior non-load bearing plate system that may be used in the thoracic, lumbar and sacral spine (T1-S1). The NuVasive ALIF Buttress Plate System, in conjuction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing applications.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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, lighter 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.
Michelle Cheung Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: January 21, 2015
B. Device Name
| Trade or Proprietary Name: | NuVasive® ALIF Buttress Plate System |
|---|---|
| Common or Usual Name: | Buttress Plate |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3060 |
| Product Code: | KWQ |
C. Predicate Devices
The subject ALIF Buttress Plate System is substantially equivalent to the following predicate devices:
Primary Predicates
- K021039, Depuy AcroMed BowTi Anterior Buttress Staple System ●
Additional Predicates
- K121837, NuVasive Brigade® Anterior Plate System ●
- K072339, NuVasive Anterior Lumbar Plate System
- K072943, X-spine Systems Butrex™ Buttress Plating System ●
- K040130, SeaSpine Anterior Lumbar Buttress System ●
- K090415, Eminent Spine Fang Plate System ●
Device Description D.
The NuVasive ALIF Buttress Plate System is an anterior non-load bearing plate system manufactured from Ti-6A1-4V per ASTM F1472 or Ti-6Al-4V ELI per ASTM F136, Nickel-Cobalt-Chromium-Molybdenum Alloy (Carpenter MP35NTM Alloy) per ASTM F562, and Nitinol SE510 per ASTM F2063. The implants are available in a variety of
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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. Below the company name is the tagline "Speed of Innovation" also in gray.
different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
E. Intended Use
The NuVasive ALIF Buttress Plate System is an anterior non-load bearing plate system that may be used in the thoracic, lumbar and sacral spine (T1-S1). The NuVasive ALIF Buttress Plate System, in conjuction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing applications.
F. Technological Characteristics
The subject ALIF Buttress Plate 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 the subject ALIF Buttress Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and Dynamic Cantilever Bending Testing per ASTM F1717-13
Conclusions H.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject ALIF Buttress Plate System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.