(114 days)
No
The document describes a passive implant (anterior cervical plate and fusion systems) and focuses on its intended use, device description, and MR safety testing. There is no mention of any software, algorithms, image processing, or data analysis that would suggest the use of AI or ML.
Yes
The device is intended for "temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, and/or failed previous fusions." Additionally, specific components are used for "anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease." These uses directly address the treatment of conditions and diseases.
No
This device is an implantable system for temporary stabilization of the anterior spine during cervical spinal fusions, not for diagnosing conditions.
No
The device description explicitly states that the systems consist of bone plates, screws, and interbody cages, which are physical hardware components implanted in the body. The submission's sole purpose is to update labeling and provide MRI safety information for these hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The descriptions clearly state that these systems are implants (bone plates, screws, interbody cages) intended for surgical implantation into the cervical spine to provide temporary stabilization during spinal fusion. They are used in the body, not to test samples from the body.
- Lack of Diagnostic Function: The intended use is for mechanical stabilization and support during the healing process of spinal fusion, not for analyzing biological samples to diagnose a condition.
Therefore, these devices fall under the category of surgical implants or spinal instrumentation, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Atlantis™ Anterior Cervical Plate System:
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 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 (DDD - 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 attachments (pedicles) of the cervical, thoracic, or lumbar spine.
Divergence™ Anterior Cervical Fusion System:
The Divergence™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. Plate and bone screw components are in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD - 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 scoliosis); 5) pseudoarthrosis; and/or 6) failed previous fusions.
The Divergence™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radios. This cage is to be used in patients who have had six weeks of non operative treatment. The Divergence™ cage must be used with supplemental fixation. The Divergence™ cage is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.
When used together, the Divergence™ components can be used only to treat cervical disc disease.
Divergence™ Anterior Cervical Fusion System (Stand-Alone Interbody)
The Divergence™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Divergence™ stand-alone cervical interbody device must be used with internal screw fixation. The Divergence™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Premier™ Anterior Cervical Plate System:
Properly used, this system is intended for anterior interbody screw fixation of the indications and contraindications of spinal instrumentation systems should be well understood by 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 (DDD - 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 attachments (pedicles) of the cervical, thoracic, or lumbar spine.
Venture™ Anterior Cervical Plate System:
Properly used, this system is intended for anterior interbody screw fixation of the indications and contraindications of spinal instrumentation systems should be well understood by 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 (DDD - 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.
Zephir™ Anterior Cervical Plate System:
Properly used, this system is intended for anterior interbody screw/plate fixation of the indications and contraindications of spinal instrumentation systems should be well understood by 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 (DDD - 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 attachments (pedicles) of the cervical, thoracic, or lumbar spine.
Zevo™ Anterior Cervical Plate System:
The Zevo™ Anterior Cervical Plate System is interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis), 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 attachments (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ, OVE, ODP
Device Description
The Medtronic Anterior Cervical Plate Systems consist of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates) and screws. The Medtronic Anterior Cervical Fusion System consist of variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates), interbody cages, and screws. Fixation is provided by bone screws and/or interbody cages inserted into the vertebral body of the cervical spine using an anterior approach. The Medtronic Anterior Cervical Plate and Fusion Systems implant components are made from titanium alloy, with certain plates having subcomponents manufactured from shape memory alloys (Nitinol-NiTi). The sole purpose for this submission is to update the labeling for the Medtronic Anterior Cervical Plate and Fusion Systems to include MRI safety information while also providing MRI technologists with a method of concluding whether a MRI scan can be performed and specific instructions on how to perform the scan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
cervical spine, anterior spine, C2 to T1, C2-C3 to C7-T1
Indicated Patient Age Range
skeletally mature patients
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)
MR Safety Testing
In accordance with the FDA Guidance “Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment” the subject Medtronic Anterior Cervical Plate Systems were evaluated for MR-safety in accordance with the following standards: ASTM F2052– “Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment” ASTM F2213– “Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment” ASTM F2119– “Standard test method for evaluation of MR image artifacts from passive implants” ASTM F2182– “Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging”
The Medtronic Anterior Cervical Plate Systems has been labeled in accordance with ASTM F2503 “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”.
Based on the supporting documentation provided in this pre-market notification, the subject Anterior Cervical Plate Systems are as safe and effective as the following predicates: Atlantis™ Anterior Cervical Plate (K152623 S.E. 11/12/2015, K130640 S.E 06/04/2013, K081038 S.E 08/15/2008, K063100 S.E 02/23/2007, K021461 S.E 07/22/2002, K970806, S.E. 05/02/1997) Divergence™ Anterior Cervical Fusion System (K140417, S.E. 07/09/2014, K141599, S.E. 01/21/2015) Premier™ Anterior Cervical Plate (K021761, S.E. 09/17/2002, K992110, S.E. 09/14/1999) Venture™ Anterior Cervical Plate (K061274 S.E. 05/25/2006, K042922 S.E. 11/19/2004) Zephir™ Anterior Cervical Plate System (K030327 S.E. 02/26/2003, K994239 S.E. 06/19/2000) Zevo™ Anterior Cervical Plate System (K141632 S.E. 12/04/2014)
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.
K152623, K130640, K081038, K063100, K021461, K970806, K140417, K141599, K021761, K992110, K061274, K042922, K030327, K994239, K141632
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 6, 2019
Medtronic Sofamor Danek USA, Inc. Ms. Kanesha Hines Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K182885
Trade/Device Name: Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate Svstem Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO. OVE. ODP Dated: January 15, 2019 Received: January 16, 2019
Dear Ms. Hines:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182885
Device Name
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System
Indications for Use (Describe)
Atlantis™ Anterior Cervical Plate System:
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 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 (DDD - 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 attachments (pedicles) of the cervical, thoracic, or lumbar spine.
Divergence™ Anterior Cervical Fusion System:
The Divergence™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. Plate and bone screw components are in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD - 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 scoliosis); 5) pseudoarthrosis; and/or 6) failed previous fusions.
The Divergence™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radios. This cage is to be used in patients who have had six weeks of non operative treatment. The Divergence™ cage must be used with supplemental fixation. The Divergence™ cage is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.
When used together, the Divergence™ components can be used only to treat cervical disc disease.
Divergence™ Anterior Cervical Fusion System (Stand-Alone Interbody)
The Divergence™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Divergence™ stand-alone cervical interbody device must be used with internal screw fixation. The Divergence™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
3
Premier™ Anterior Cervical Plate System:
Properly used, this system is intended for anterior interbody screw fixation of the indications and contraindications of spinal instrumentation systems should be well understood by 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 (DDD - 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 attachments (pedicles) of the cervical, thoracic, or lumbar spine.
Venture™ Anterior Cervical Plate System:
Properly used, this system is intended for anterior interbody screw fixation of the indications and contraindications of spinal instrumentation systems should be well understood by 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 (DDD - 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.
ZephirTM Anterior Cervical Plate System:
Properly used, this system is intended for anterior interbody screw/plate fixation of the indications and contraindications of spinal instrumentation systems should be well understood by 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 (DDD - 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 attachments (pedicles) of the cervical, thoracic, or lumbar spine.
Zevo™ Anterior Cervical Plate System:
The Zevo™ Anterior Cervical Plate System is interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis), 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 attachments (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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
MEDTRONIC Sofamor Danek MRI Update for Medtronic Anterior Cervical Plate Systems
January 2019
| Submitter: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kanesha Hines
Regulatory Affairs Specialist
Direct Telephone: (901)399-2670 |
| Date Prepared | January 15, 2019 |
| Name of Device | Medtronic Anterior Cervical Plate and Fusion Systems (Atlantis™
Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion
System, Premier™ Anterior Cervical Plate, Venture™ Anterior
Cervical Plate, Zephir™ Anterior Cervical Plate System and
Zevo™ Anterior Cervical Plate System) |
| Common Name | Appliance, Fixation, Spinal Intervertebral Body |
| Trade Name | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior
Cervical Fusion System, Premier™ Anterior Cervical Plate,
Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical
Plate System and Zevo™ Anterior Cervical Plate System |
| Regulatory Class,
Regulation Number,
Regulation Name, and
Device Product Code | Class II 21 CFR 888.3060 Spinal Intervertebral Body Fixation Orthosis; KWQ, 21 CFR 888.3080 Intervertebral body fusion device OVE, ODP |
| Predicate Devices | Primary Predicate 1- K152623 Atlantis™ Anterior Cervical Plate System (S.E 11/12/2015) Predicate 2- K130640 Atlantis™ Anterior Cervical Plate System (S.E 06/04/2013) Predicate 3- K081038 Atlantis™ Anterior Cervical Plate System (S.E 08/15/2008) Predicate 4- K063100 Atlantis™ Anterior Cervical Plate System (S.E 02/23/2007) Predicate 5- K021461 Atlantis™ Anterior Cervical Plate System (S.E 07/22/2002) |
| | Predicate 6- K970806 Atlantis™ Anterior Cervical Plate System (S.E 05/02/197) Predicate 7- K140417 Divergence™ Anterior Cervical Fusion System (S.E. 07/09/2014) Predicate 8- K141599 Divergence™ Anterior Cervical Fusion System (S.E. 01/21/2015) Predicate 9- K021761 Premier™ Anterior Cervical Plate System (S.E 09/17/2002) Predicate 10- K992110 Premier™ Anterior Cervical Plate System (S.E 09/14/1999) Predicate 11- K061274 Venture™ Anterior Cervical Plate System (S.E 05/25/2006) Predicate 12- K042922 Venture™ Anterior Cervical Plate System (S.E 11/19/2004) Predicate 13- K030327 Zephir™ Anterior Cervical Plate System (S.E. 02/26/2003) Predicate 14- K994239 Zephir™ Anterior Cervical Plate System (S.E. 06/19/2000) Predicate 15- K141632 Zevo™ Anterior Cervical Plate System (S.E. 12/04/2014) The predicates have not been subject to a design related recall. |
| Description of Devices | The Medtronic Anterior Cervical Plate Systems consist of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates) and screws. The Medtronic Anterior Cervical Fusion System consist of variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates), interbody cages, and screws. Fixation is provided by bone screws and/or interbody cages inserted into the vertebral body of the cervical spine using an anterior approach. The Medtronic Anterior Cervical Plate and Fusion Systems implant components are made from titanium alloy, with certain plates having subcomponents manufactured from shape memory alloys (Nitinol-NiTi). The sole purpose for this submission is to update the labeling for the Medtronic Anterior Cervical Plate and Fusion Systems to include MRI safety information while also providing MRI technologists with a method of concluding whether a MRI scan can be performed and specific instructions on how to perform the scan. |
| Indications for Use | Atlantis™ Anterior Cervical Plate System:
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 |
6
7
in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - 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 posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Divergence™ Anterior Cervical Fusion System:
The Divergence™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. Plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD - 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) pseudoarthrosis; and/or 6) failed previous fusions.
The Divergence™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord
compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non operative treatment. The Divergence™ cage must be used with supplemental fixation. The Divergence™ cage is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.
When used together, the Divergence™ components can be used only to treat cervical disc disease.
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| Divergence™ Anterior Cervical Fusion System (Stand-Alone
| Interbody) | |
|---|---|
| The Divergence™ Anterior Cervical Fusion System consists of a | |
| stand-alone interbody device indicated for use in anterior cervical | |
| interbody fusion procedures in skeletally mature patients with | |
| cervical disc disease at one level from C2-C3 to C7-T1. Cervical | |
| disc disease is defined as intractable radiculopathy and/or | |
| myelopathy with herniated disc and/or osteophyte formation on | |
| posterior vertebral endplates producing symptomatic nerve root | |
| and/or spinal cord compression confirmed by radiographic | |
| studies. The Divergence™ stand-alone cervical interbody device | |
| must be used with internal screw fixation. The Divergence™ | |
| stand-alone cervical interbody device is also required to be used | |
| with autogenous bone graft and is to be implanted via an open, | |
| anterior approach. This cervical device is to be used in patients | |
| who have had six weeks of nonoperative treatment. Patients with | |
| previous non-fusion spinal surgery at involved level may be | |
| treated with the device. | |
| Premier™ Anterior Cervical Plate System: | |
| Properly used, this system is intended for anterior interbody | |
| screw 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 (DDD - 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 | |
| posterior elements (pedicles) of the cervical, thoracic, or lumbar | |
| spine. | |
| Venture™ Anterior Cervical Plate System: | |
| Properly used, this system is intended for anterior interbody | |
| screw 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 (DDD - 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. |
Zephir™ Anterior Cervical Plate System:
Properly used, this system is intended for anterior interbody
screw/plate fixation of the cervical spine. The indications andwell 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 (DDD - 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
posterior elements (pedicles) of the cervical, thoracic, or lumbar
spine. |
| | Zevo™ Anterior Cervical Plate System:
The Zevo™ Anterior Cervical Plate System is intended for
anterior interbody screw fixation from C2 to T1. The system is
indicated for use in the temporary stabilization of the anterior
spine during development of cervical spinal fusions in patients
with: 1) degenerative disc disease (DDD - 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
posterior elements (pedicles) of the cervical, thoracic, or lumbar
spine. |
| Comparison of
Technological
Characteristics with the
Predicate Devices: | The subject devices do not differ from the technological
characteristics of the predicate devices. |
| Performance Data: | The following performance data were provided in support of |
| | substantial equivalence. |
| | MR Safety Testing
In accordance with the FDA Guidance “Establishing Safety and
Compatibility of Passive Implants in the Magnetic Resonance
(MR) Environment” the subject Medtronic Anterior Cervical Plate
Systems were evaluated for MR-safety in accordance with the
following standards: ASTM F2052– “Standard test method for measurement
of magnetically induced displacement force on passive
implants in the magnetic resonance environment” ASTM F2213– “Standard test method for measurement
of magnetically induced torque on medical devices in
the magnetic resonance environment” ASTM F2119– “Standard test method for evaluation of
MR image artifacts from passive implants” ASTM F2182– “Standard test method for measurement
of radio frequency induced heating on or near passive
implant during magnetic resonance imaging” |
| | The Medtronic Anterior Cervical Plate Systems has been labeled
in accordance with ASTM F2503 “Standard Practice for Marking
Medical Devices and Other Items for Safety in the Magnetic
Resonance Environment”.
Based on the supporting documentation provided in this pre-
market notification, the subject Anterior Cervical Plate Systems
are as safe and effective as the following predicates: Atlantis™ Anterior Cervical Plate (K152623 S.E.
11/12/2015, K130640 S.E 06/04/2013, K081038 S.E
08/15/2008, K063100 S.E 02/23/2007, K021461 S.E
07/22/2002, K970806, S.E. 05/02/1997) Divergence™ Anterior Cervical Fusion System (K140417,
S.E. 07/09/2014, K141599, S.E. 01/21/2015) Premier™ Anterior Cervical Plate (K021761, S.E.
09/17/2002, K992110, S.E. 09/14/1999) Venture™ Anterior Cervical Plate (K061274 S.E.
05/25/2006, K042922 S.E. 11/19/2004) Zephir™ Anterior Cervical Plate System (K030327 S.E.
02/26/2003, K994239 S.E. 06/19/2000) Zevo™ Anterior Cervical Plate System (K141632 S.E.
12/04/2014) |
| Conclusion: | |
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