(87 days)
Not Found
No
The 510(k) summary describes a mechanical implant (cervical plate system) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing standards.
Yes.
The device is used for temporary stabilization and fusion of the cervical spine to treat various medical conditions such as degenerative disk disease, trauma, tumor, and deformity, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a cervical plate system used for temporary stabilization and fusion of the cervical spine, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states the system consists of titanium cervical plates and screw components, which are physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary stabilization of the anterior spine during cervical spine fusions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of titanium plates and screws, which are implanted surgically.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as an implant for structural support.
N/A
Intended Use / Indications for Use
The Cardo Medical Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (including fracture); tumor; deformity (defined as kyphosis, lordosis or scollosis): pseudoarthrosis: and/or failed previous fusions. The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.
Product codes (comma separated list FDA assigned to the subject device)
KWO
Device Description
The Cardo Medical Cervical Plate System consists of titanium cervical plates and both self-tapping and self-drilling screw components. The surgeon uses the components to make a construct that is placed anteriorly for spinal fixation. The construct is used for temporary fixation which allows for fusion of the cervical spine. The modified system includes the addition of a fixed angle cervical screw as an option for the surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, sub-axial cervical spine from C3 through 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)
Tests were performed on the cervical plate system. The testing was performed in accordance with ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectorny Model. The proposed device was equivalent to the predicate device for all testing performed.
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.
K040003, K043181, K051815, K062110, K081567, K073530
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
Cardo Medical Cervical Plate System Premarket Notification Submission - 510(k)
Summary of Safety and Effectiveness
AUG 05 2009
ri
| Submitter: | Denise Duchene
Cardo Medical Corporation
1033 US Highway 46, Suite A204
Clifton, NJ 07103 |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 4, 2009 |
| Device: | Cardo Medical Cervical Plate System |
| Classification: | 87KWQ - Appliance, Fixation, Spinal Intervertebral Body, 21CFR 880.3060,
Class II |
| Predicate Device: | Vertebron Cervical Plate Systems - K040003, K043181, K051815, K062110 and
K081567. Cardo Medical Cervical Plate System K073530 |
| Device Description: | The Cardo Medical Cervical Plate System consists of titanium cervical plates and
both self-tapping and self-drilling screw components. The surgeon uses the
components to make a construct that is placed anteriorly for spinal fixation. The
construct is used for temporary fixation which allows for fusion of the cervical
spine. The modified system includes the addition of a fixed angle cervical screw
as an option for the surgeon. |
| Intended Use: The Cardo Medical Cervical Plate System is intended for anterior interbody fixation of the | |
Medical Cervical Plate System is intended for anterior interb cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (including fracture); tumor; deformity (defined as kyphosis, lordosis or scollosis): pseudoarthrosis: and/or failed previous fusions. The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.
Comparison to Predicates:
The Cardo Medical Cervical Plate System consists of plates and screws manufactured from the same titanium alloy as the Vertebron, Inc. Cervical Plate Systems. Therefore, the devices are equivalent to the Vertebron, Inc. Cervical Plate System.
Cardo Medical has determined that any differences in the proposed device will not impact the safety or effectiveness of the cervical plate system for its intended use. Testing has shown that the proposed device meets the requirements of the current FDA Guidance document entitled "Spinal System 510(k)s" dated May 3, 2004, and that the proposed device is equivalent to the predicate device.
Synopsis of Test Methods and Results:
Tests were performed on the cervical plate system. The testing was performed in accordance with ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectorny Model. The proposed device was equivalent to the predicate device for all testing performed.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a modern, abstract design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Cardo Medical Corporation % Ms. Denise Duchene 1033 US Highway 46, Suite A204 Clifton, New Jersey 07103
AUG 0 5 2009
Re: K091396
Trade/Device Name: Cardo Medical Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: May 8, 2009 Received: May 10, 2009
Dear Ms. Duchene:
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.
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 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.
2
Page 2 -- Ms. Denise Duchene
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director
Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Cardo Medical Cervical Plate System Premarket Notification Submission - 510(k)
Indications for Use Form
510(k) Number (if known):
Device Name: Cardo Medical Cervical Plate System
Indications for Use:
The Cardo Medical Cervical Plate System components are intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with:
- Degenerative disk disease (as defined by neck pain of discogenic origin with ● degeneration of the disc confirmed by history and radiographic studies);
- Trauma (including fractures) .
- Tumor ●
- Deformity (defined as kyphosis, lordosis or scollosis) .
- Pseudoarthrosis .
- Failed previous fusions. ●
The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
$E*{a} = Z(EX*{n}X_{n})
Page 1 of 1
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K 091396