(136 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an implantable system for spinal fusion, which is used to treat conditions like degenerative disc disease, trauma, tumors, and deformity, indicating its therapeutic purpose in stabilizing the spine.
No
The device description clearly states that the ATLANTIS® Anterior Cervical Plate System components are "temporary implants" intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. This describes a surgical implant used for stabilization, not a device designed to identify or analyze disease or conditions.
No
The device description explicitly states that the system consists of bone plates, screws, and associated instruments, which are physical hardware components intended for implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "anterior interbody screw/plate fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spinal fusions." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details "bone plates, screws, and associated instruments" made from titanium alloy and Nitinol, which are materials used for surgical implants. It also describes the mechanism of fixation as "bone screws inserted into the vertebral body."
- 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 treatment. IVDs are typically used in laboratories or point-of-care settings for testing purposes.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scollosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The ATLANTIS® Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion.
The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
The ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having subcomponents manufactured from a superelastic alloy (Nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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)
Mechanical testing was provided demonstrating that the subject ATLANTIS® Translational Plate and subject screws are substantially equivalent to other commercially available anterior cervical fixation systems and other pre-enactment devices ing the ZEPHIR® Anterior Cervical System (K030327, SE 02/26/2003) and the ATLANTIS® Anterior Cervical Plate System (K021461, SE 07/22/2002). The esubject equivalent to or better than the testing performed for the ZEPHIR® Anterior Cervical System.
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
K063100
Page 1 of 2
ATLANTIS® Anterior Cervical Plate System ATLANTIS® Translational Plate
FEB 2 3 2007
510(k) Summary
February 2007
I. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Contact:
Edward S. Chin, D. Ph., MBA Group Director, Regulatory and Clinical Affairs
- Proposed Proprietary Trade Name: ATLANTIS® Anterior Cervical Plate System II.
- Classification Name(s): Spinal Intervertebral Body Fixation Orthosis; Class: II; III. Product Code(s): KWQ; and Regulation No .: 888.3060
- Legally Marketed Devices: ZEPHIR® Anterior Cervical System (K030327), ATLANTIS® IV. Anterior Cervical Plate System (K021461)
- Description: The ATLANTIS® Anterior Cervical Plate System components are temporary V. implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion.
The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
The ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having subcomponents manufactured from a superelastic alloy (Nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct.
- VI. Indications for Use: Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scollosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
1
- VII. Substantial Equivalence: Mechanical testing was provided demonstrating that the subject ATLANTIS® Translational Plate and subject screws are substantially equivalent to other commercially available anterior cervical fixation systems and other pre-enactment devices ing the ZEPHIR® Anterior Cervical System (K030327, SE 02/26/2003) and the
ATLANTIS® Anterior Cervical Plate System (K021461, SE 07/22/2002). The esubject equivalent to or better than the testing performed for the ZEPHIR® Anterior Cervical System.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Sofamor Danek USA, Incorporated c/o Ms. Christine Scifert Group Director, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132
FEB 2 3 2007
K063100 Re:
Trade/Device Name: ATLANTIS™ Anterior Cervical Plate System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 06, 2006 Received: October 10, 2006
Dear Ms. Scifert:
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.
3
Page 2 - Ms. Christine Scifert
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,
Barbara buelmo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
Page 1 of October 2006
KO63100 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scollosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
AND/OR Prescription Use Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Farhare Buchmp
Division of General, Restorative, and Neurological Devices
510(k) Number K043100