(27 days)
Not Found
No
The summary describes a mechanical implant (screws and plates) and mentions only biomechanical testing. There is no mention of software, image processing, AI, ML, or data sets.
No
The device is described as a surgical implant (screws and plates) used in spinal fusion procedures to maintain relative position, not to treat and/or cure a disease or condition.
No
Explanation: The device is described as a "Zavation Buttress Plate System" intended for use in spinal fusion procedures to maintain the relative position of weak bony tissue. This clearly indicates it is a surgical implant used for structural support, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "screws and plates," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts." This describes a surgical implant used in vivo (within the body) during a procedure.
- Device Description: The description of "screws and plates" further confirms it's a physical implant.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device does not perform any such testing on specimens.
The information provided describes a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Zavation Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Zavation Buttress Plate System consists of screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
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)
Biomechanical testing, including static and fatigue cantilever beam loading were conducted.
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.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 27, 2018
Zavation Medical Products LLC Matt Jones Design Engineer 220 Lakeland Parkway Flowood, Mississippi 39232
Re: K180537
Trade/Device Name: Zavation Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 27, 2018 Received: February 28, 2018
Dear Matt Jones:
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 of medical device-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.
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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.
For comprehensive regulatory information about medical devices and radiation-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,
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) K180537
Device Name Zavation Buttress Plate System
Indications for Use (Describe)
The Zavation Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary
| Date: | February 27, 2018 |
|---|---|
| Submitter: | Zavation Medical Products LLC |
| 220 Lakeland Pkwy | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact Person: | Matt Jones |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation Buttress Plate System |
| Common name: | Anterior Buttress Plate |
| Classification regulation: | 888.3060 |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | KWQ |
Device Description:
The Zavation Buttress Plate System consists of screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
Intended Use:
The Zavation Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
Materials:
The Zavation Buttress Plate System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.
Primary Predicate Device:
K081770 Black Widow Anterior Buttress Plate System [Spinal Elements]
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Additional Predicate Devices:
K061482 Altes Anterior Buttress Plating System [Exactech Spine] K112533 Zavation Cervical Plate System [Zavation]
Technological Characteristics:
The Zavation Buttress Plate System possesses the same technological characteristics as the predicates. These include: basic design (plate designed system having various screw diameters and lengths), material (titanium alloy), sizes (variety of plate and screw sizes), and intended use (as described above).
Performance Data:
Biomechanical testing, including static and fatigue cantilever beam loading were conducted.
Conclusion:
The Zavation Buttress Plate System is substantially equivalent to the devices referenced above.