(82 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a spinal fixation system that provides immobilization and stabilization of cervical segments of the spine for various medical indications, including degenerative disc disease, trauma, and tumors, which are therapeutic purposes.
No
The device is a spinal fixation system, which functions as an adjunct to fusion for immobilization and stabilization of cervical segments of the spine, not for diagnosing conditions. Its intended use lists various indications but the device itself is for treatment/fixation.
No
The device description explicitly states that the Pyrenees Cervical Plate System consists of cervical screws and plates made from titanium, 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 intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Pyrenees Cervical Plate System is a spinal fixation system consisting of plates and screws. Its function is to provide immobilization and stabilization of cervical segments of the spine as an adjunct to fusion.
- Intended Use: The intended use is for anterior screw fixation to the cervical spine for various conditions. This is a surgical implant, not a device used to test biological samples.
The information provided clearly describes a surgical implant used directly on the patient's anatomy, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The Pyrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications : degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
Product codes
KWO
Device Description
The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
- Materials: The devices are manufactured from Commercially Pure titanium and titanium alloy per ASTM and ISO standards.
- Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.
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
Prescription use
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)
Testing in accordance with ASTM F1717 was performed and demonstrated that the modified Pyrenees Cervical Plate System is substantially equivalent to the current cleared Pyrenees Cervical Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K926486) and the Interpore Cross Anterior Cervical Plate System (K002592).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060442, K971883, K000538, K051531, K971730, K926486, K002592
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.
0
FFB 1 4 2007
510(k) Summary Pyrenees Cervical Plate System K2M, Inc.
This safety and effectiveness summary for the Pyrenees Cervical Plate System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
1. Submitter :
K2M, Inc. 751 Miller Drive SE Suite F 1 Leesburg, VA 20175
Contact Person :
Richard W. Woods K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: 703-777-3155
Date Prepared: November 21, 2006
2. Tradename: Pyrenees Cervical Plate System Common Name: Anterior Cervical Plate Spinal Intervertebral Body Fixation Orthosis ( 888.3060 ) Classification Name:
3. Description of the device:
The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
- Materials: The devices are manufactured from Commercially Pure titanium and titanium alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.
4. Intended Use:
The Pvrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications : degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
5. Predicate or legally marketed devices which are substantially equivalent:
Testing in accordance with ASTM F1717 was performed and demonstrated that the modified Pyrenees Cervical Plate System is substantially equivalent to the current cleared Pyrenees Cervical Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K926486) and the Interpore Cross Anterior Cervical Plate System (K002592).
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
There are no significant differences between the Pyrenees Cervical Plate System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K2M, Limited Liability Company c/o Mr. Richard Woods Senior Vice President 751 Miller Drive, SE, Suite F-1 Leesburg, Virginia 20175
FFB 1 4 7007
Re: K063544
Trade/Device Name: Pyrenees Cervical Plate System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: November 21, 2006 Received: November 28, 2006
Dear Mr. Woods:
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 such 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.
2
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k): K063544
Pyrenees Cervical Plate System Device Name :
Indications For Use :
The Pyrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity ( defined as scoliosis, kyphosis or lordosis).
Prescription use >> OR
Over-the-counter use ( PER 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
#============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation ( ODE )
Division Sign-Of
(Division Sign-Off) Division of General, Restorative, and Neurological I
510(k) Number