(59 days)
Not Found
No
The 510(k) summary describes a mechanical spinal implant system and associated instruments. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on sterilization, shelf life, and mechanical testing, which are typical for this type of device.
Yes
The device is described as an implantable system intended for the temporary stabilization of the anterior spine during cervical spinal fusions, addressing various medical conditions such as degenerative disc disease, trauma, tumors, and deformities. Implants used to treat disease or injury fall under the definition of therapeutic devices.
No
Explanation: The device is an ATLANTIS® Anterior Cervical Plate System intended for temporary stabilization and fusion of the anterior spine. It is an implantable medical device used in surgery, not a diagnostic tool. Its purpose is mechanical support and fixation, not to diagnose a condition.
No
The device description explicitly states that the system consists of bone plates, screws, and associated instruments made from titanium alloy and shape memory alloys. These are physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "anterior interbody screw fixation from C2 to T1" 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 instruments made from titanium alloy and Nitinol. These are physical components designed for surgical implantation.
- 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 a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. 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 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, lordosis, or scoliosis), 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
KWQ
Device Description
The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the 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 shape memory alloys (Nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct. Do not use any of the ATLANTIS® Anterior Cervical Plate System components with the components from any other system or manufacturer.
The subject devices are manufactured from ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications.
The subject plates and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2 to T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Sterilization assessments were completed for the sterile subject plates and screws. These reports provide adequate evidence for the validated sterilization parameters. The shelf life rationale indicates that the sterile subject device package integrity has an eight year shelf life. Mechanical testing, in accordance with ASTM F1717, was also completed to support the subject device's substantial equivalence to the predicate devices. The test methods included compression fatigue, static compression, and static torsion. Compression fatigue, static torsion, and static compression testing were completed, and the test results determined the subject devices to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021461, K063100, K130640, K141632
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Laveeda Leflore Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
November 12, 2015
Re: K152623
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: September 11, 2015 Received: September 14, 2015
Dear Ms. Leflore:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Laveeda Leflore
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
2
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
ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM
Indications for Use (Describe)
Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. 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 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, lordosis, or scoliosis), 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.
| 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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3
| ATLANTIS® Anterior Cervical Plate System
| 510(k) Summary – November 09, 2015 | |
|---|---|
| I. Company: | Medtronic Sofamor Danek USA, Inc. |
| 1800 Pyramid Place | |
| Memphis, TN 38132 | |
| (901) -396-3133 |
Contact:
Laveeda Leflore
Regulatory Affairs Specialist |
| II. Proprietary Trade Name: | ATLANTIS® Anterior Cervical Plate System |
| III. Classification Name: | Spinal Intervertebral Body Fixation Orthosis
(888.3060) |
| IV. Classification: | Class II |
| V. Predicate Devices | K021461 ATLANTIS® Anterior Cervical Plate System (S.E. 07/22/2002) – Primary Predicate
K063100 ATLANTIS® Anterior Cervical Plate System (S.E. 02/23/2007)
K130640 ATLANTIS® Anterior Cervical Plate System (S.E. 06/04/2013)
K141632 ZEVO® Anterior Cervical Plate System (S.E. 12/04/2014) |
VI. Product Codes: KWQ
VII. Product Description
The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the 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 shape memory alloys (Nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct. Do not use any of the ATLANTIS® Anterior
4
Cervical Plate System components with the components from any other system or manufacturer.
The subject devices are manufactured from ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications.
The subject plates and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.
VIII. Indications for Use
Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. 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, lordosis, or scoliosis), 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.
VII. Summary of the Technological Characteristics
The subject devices are identical to the predicate in terms of intended use, overall dimensions, and fundamental scientific technology as the previously cleared predicates. Like the predicates, the subject plates and bone screws are available in titanium alloy. Also like the predicates, the plates are offered in sizes ranging from 19mm- 110mm, and the bone screws are offered in sizes 4.0mm and 4.5mm in diameter and 10-20mm in length. The subject plates and bone screws will be provided sterile.
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VIII. Identification of Legally Marketed Devices
The design features and indications for use for the sterile subject devices are substantially equivalent to the predicate ATLANTIS® Anterior Cervical Plate System (K021461, S.E. 07/22/2002; K063100 S.E. 02/23/2007; K130640 S.E. 06/04/2013) and ZEVO® Anterior Cervical Plate System (K141632 S.E. 12/04/2014).
IX. Discussion of Non-Clinical Testing:
Sterilization assessments were completed for the sterile subject plates and screws. These reports provide adequate evidence for the validated sterilization parameters. The shelf life rationale indicates that the sterile subject device package integrity has an eight year shelf life. Mechanical testing, in accordance with ASTM F1717, was also completed to support the subject device's substantial equivalence to the predicate devices. The test methods included compression fatigue, static compression, and static torsion. Compression fatigue, static torsion, and static compression testing were completed, and the test results determined the subject devices to be substantially equivalent to the predicate devices. A summary of the testing performed along with the complete test report is provided in the Bench Testing section of this submission.
Conclusion X.
Based on the non-clinical test results and additional supporting documentation provided in this pre-market notification, Medtronic believes that the subject devices demonstrated substantial equivalence to the listed predicate devices.