(25 days)
Not Found
No
The description focuses on the mechanical design and materials of a spinal implant, with no mention of AI or ML capabilities. The submission purpose is related to package insert modifications, not technological changes.
Yes
Explanation: The device is a vertebral body replacement device intended to repair a damaged or unstable vertebral body due to tumor or trauma, which is a form of treatment.
No
The device is a vertebral body replacement device, intended for reconstructive surgery to replace a collapsed, damaged, or unstable vertebral body. It is a treatment device, not a diagnostic one.
No
The device description clearly states it consists of physical components made of PEEK and metal, which are implanted in the spine. It is a hardware device.
Based on the provided information, the VERTE-STACK® Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a vertebral body replacement device for use in the thoracolumbar spine due to tumor or trauma. This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details the physical components of the implant (cages, materials) and how they are assembled and used in a surgical procedure. This aligns with a medical device intended for implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the VERTE-STACK® Spinal System is a medical device, specifically a surgical implant, and not an IVD.
N/A
Intended Use / Indications for Use
The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, the GDLH® Spinal System and/or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.
Product codes
MQP
Device Description
The VERTE-STACK® device consists of hemi-cylindrical center cages of various lengths and diameters, as well as hemi-cylindrical add on cages of various lengths, diameters and angulation. The assembled VERTE-STACK® device consists of three components (one hollow center cage, and two hollow add-on cages). The VERTE-STACK® components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.
The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
The VERTE-STACK® Spinal System implant components are made of medical grade PEEK-OPTIMA LT1 along with a marker made from either Tantalum or titanium. Alternatively, VERTE-STACK® Spinal System may be manufactured from titanium alloy.
The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured from PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.
The purpose of this submission was to modify the wording of the VERTE-STACK® Spinal System package insert by removing certain contraindications and by including a NOTA BENE for potential factors to consider with regards to when not to use this device. The rewording of the document makes it more consistent with that of the package insert for the CD HORIZON® Spinal System, which may be used as the supplemental fixation device for the VERTE-STACK® device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
VERTE-STACK® Spinal System 510(k) Summary August 2006
| I. | Company: | Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, TN 38132
(901) 396-3133 | SEP 12 2006 |
---- | ---------- | -------------------------------------------------------------------------------------- | ------------- |
---|
Edward S. Chin, D. Ph, MBA Contact: Group Director, Regulatory and Clinical Affairs
- Proprietary Trade Name: VERTE-STACK® Spinal System II.
- Classification Name/Product Code: Spinal Intervertebral Body Fixation Orthosis III. (21 CFR 888.3060)
- Product Code: MQP IV.
V. Product Description
The VERTE-STACK® device consists of hemi-cylindrical center cages of various lengths and diameters, as well as hemi-cylindrical add on cages of various lengths, diameters and angulation. The assembled VERTE-STACK® device consists of three components (one hollow center cage, and two hollow add-on cages). The VERTE-STACK® components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.
The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
The VERTE-STACK® Spinal System implant components are made of medical grade PEEK-OPTIMA LT1 along with a marker made from either Tantalum or titanium. Alternatively, VERTE-STACK® Spinal System may be manufactured from titanium alloy.
The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured from PEEK may be used with stainless steel or titanium supplemental
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fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.
The purpose of this submission was to modify the wording of the VERTE-STACK® Spinal System package insert by removing certain contraindications and by including a NOTA BENE for potential factors to consider with regards to when not to use this device. The rewording of the document makes it more consistent with that of the package insert for the CD HORIZON® Spinal System, which may be used as the supplemental fixation device for the VERTE-STACK® device.
V. Indications
The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, the GDLH® Spinal System and/or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.
VI. Substantial Equivalence
Documentation was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to the previously cleared VERTE-STACK® Spinal System components most recently cleared in K061938, SE 08/15/2006; and to the CD HORIZON® Spinal System, as cleared in K061304, SE 07/18/2006.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures representing health, services, and human needs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Sofamor Danek % Edward S. Chin D. Ph, MBA Group Director, Regulatory and Clinical Affairs 1800 Pyramid Place Memphis, Tennessee 38132
SEP 1 2 2006
Re: K062427
Trade/Device Name: VERTE-STACK® Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 17, 2006 Received: August 18, 2006
Dear Mr. Chin:
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, and 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); 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.
3
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,
Kaibare Buchund
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: VERTE-STACK® Spinal System
Indications for Use:
The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Barbara Breard for mkm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_4062427