(48 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for spinal fusion and does not mention any software, image processing, or AI/ML capabilities.
No
The device provides mechanical stabilization for the cervical spine as an adjunct to fusion, rather than directly treating a disease or condition with therapeutic action.
No
This device is a surgical implant designed to provide stabilization to the cervical spine as an adjunct to fusion; it does not diagnose medical conditions.
No
The device description explicitly states it is comprised of non-sterile, single-use implantable components fabricated from Titanium alloy, including screws and plates, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Amendia Cervical Plate System is a system of implants (plates and screws) made of titanium alloy. These are surgically implanted into the cervical spine to provide stabilization.
- Intended Use: The intended use is for anterior screw fixation of the cervical spine as an adjunct to fusion, addressing various spinal conditions. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
The device is a surgical implant used for structural support and stabilization within the body, which is fundamentally different from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amendia Cervical Plate System is intended for use in anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), tumor, pseudoarthosis or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Amendia Cervical Plate System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from Titanium alloy (Ti-6Al-4V, ASTM F136). The Amendia Cervical Plate System provides stabilization of cervical segments of the spine. The system consists of self-tapping/self-drilling 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
cervical spine (C2-C7)
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)
The substantial equivalence of the Subject Device to the predicate is shown by both having the same intended use, indications for use, materials, and performance specifications. A risk analysis was performed, which demonstrated that the subject device does not introduce new issues of safety or effectiveness.
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.
Zavation Cervical Plate System (K130030)
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 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2015
Amendia, Incorporated Ms. Kristen Allen Senior Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062
Re: K152455
Trade/Device Name: Amendia Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 27, 2015 Received: August 28, 2015
Dear Ms. Allen:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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/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 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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known)
Device Name Amendia Cervical Plate System
Indications for Use (Describe)
The Amendia Cervical Plate System is intended for use in anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), tumor, pseudoarthosis or failed previous fusion.
| 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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510(k) Summary
Amendia Cervical Plate System
| Submitter: | Amendia, Inc.
1755 W. Oak Parkway
Marietta, GA 30062 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristen Allen
Sr. Regulatory Affairs Specialist
910-612-4153 (P), 877-420-1213 (F)
kallen@amendia.com (e-mail) |
| Date Prepared: | August 27, 2015 |
| Trade Name: | Amendia Cervical Plate System |
| Common Name: | Spinal Intervertebral body fixation orthosis |
| Device Product Code
and Classification: | KWQ, Class II (§888.3060) |
| Primary Predicate: | Zavation Cervical Plate System (K130030) |
Device Description:
The Amendia Cervical Plate System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from Titanium alloy (Ti-6Al-4V, ASTM F136). The Amendia Cervical Plate System provides stabilization of cervical segments of the spine. The system consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
Indications and Intended use:
The Amendia Cervical Plate System is intended for use in anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), tumor, pseudoarthosis or failed previous fusion.
Summary of Technological Characteristics:
The Amendia Cervical Plate System is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to be identical to the predicate device in terms of design, intended use, performance specifications, material specifications, and technological characteristics.
Summary of Performance Testing:
The substantial equivalence of the Subject Device to the predicate is shown by both having the same intended use, indications for use, materials, and performance specifications. A risk analysis
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Image /page/4/Picture/0 description: The image shows the logo for Amendia. The logo features the word "AMENDIA" in a sans-serif font, with the "A" in a blue square. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller font. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
was performed, which demonstrated that the subject device does not introduce new issues of safety or effectiveness.
Conclusion:
Based on the comparison to predicate devices and performance testing, the Amendia Cervical Plate System has been shown to be substantially equivalent to the legally marketed predicate device.