(21 days)
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks: The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. The use of the occipitocervical plate/rod requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks and Rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-axial Screws/Connectors: The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plate/rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATI.A.S® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations. The VERTEX® Reconstruction System is fabricated from medical grade titanium or titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances. The purpose of this submission was to add modified components to the system including cannulated screws, set screws and a longer medical grade titanium 5.5mm rod.
The provided text describes a 510(k) submission for the VERTEX® Reconstruction System, a spinal fixation device, and not a software algorithm or AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria and studies for device performance in the context of AI (e.g., sample sizes for test sets, expert ground truth, MRMC studies) is not applicable to this submission.
However, I can extract the relevant information about how the device meets acceptance criteria, which, for a physical medical device, primarily revolves around substantial equivalence to a legally marketed predicate device, supported by mechanical testing where appropriate.
Here's a breakdown of the provided information within the framework of your request, noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
For this medical device, the primary "acceptance criterion" for regulatory clearance is Substantial Equivalence to a predicate device. The "performance" reported is essentially the demonstration of this equivalence.
| Acceptance Criterion (Regulatory) | Reported Device Performance |
|---|---|
| Substantial Equivalence to a legally marketed predicate device. | Documentation, including mechanical test results, was provided demonstrating that the subject VERTEX™ Reconstruction System components (modified components including cannulated screws, set screws, and a longer medical grade titanium 5.5mm rod) are substantially equivalent to VERTEX® Reconstruction System components previously cleared in K042789 (SE 12/21/04). The labeling is identical to that cleared in K052734 (SE 10/21/05). |
| Adherence to general controls provisions of the Act (e.g., registration, listing, GMP, labeling, misbranding, adulteration). | This is implicitly accepted by the FDA's clearance letter, stating that the device is subject to these provisions and allows the company to market it. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in the context of an AI/software test set. This is a spinal implant.
- For the mechanical tests mentioned, the specific sample sizes for components tested are not detailed in this summary. The data provenance (e.g., where the tests were performed) is also not specified. These are typically performed in a lab setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is not an AI diagnostic device that relies on expert ground truth for image interpretation or similar. The "ground truth" for a physical device like this is its mechanical properties and biocompatibility, as demonstrated through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This concept is for clinical studies or AI performance evaluations, not for a 510(k) submission based on substantial equivalence and mechanical testing of an orthopedic implant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is an orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. No algorithm is being submitted for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the purpose of demonstrating substantial equivalence, the "ground truth" implicitly relies on:
- Mechanical properties benchmarks: The performance of the predicate device (K042789) and established industry standards for spinal implant mechanics.
- Material properties: Conformance to medical-grade titanium and titanium alloy specifications, and the Nitinol properties for the retaining ring.
8. The sample size for the training set
- Not Applicable. No AI model is being trained.
9. How the ground truth for the training set was established
- Not Applicable. No AI model is being trained.
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2006 jan 5
VERTEX® Reconstruction System 510(k) Summary December 2005
| I. | Company: | Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132(901) 396-3133 |
|---|---|---|
| Contact: | Richard W. Treharne, Ph.D.Senior Vice President, Regulatory Affairs | |
| II. | Product Name: | VERTEX Reconstruction System |
| Classification Name: | Spinal Interlaminal Fixation OrthosisPedicle Screw Spinal System | |
| Regulation Number:Code: | 888.3050, 888.3070KWP, MNI |
III. Description:
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plate/rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATI.A.S® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.
The VERTEX® Reconstruction System is fabricated from medical grade titanium or titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct.
To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.
The purpose of this submission was to add modified components to the system including cannulated screws, set screws and a longer medical grade titanium 5.5mm rod.
{1}------------------------------------------------
IV Indications
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
The use of the occipitocervical plate/rod requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-axial Screws/Connectors
The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
V. Substantial Equivalence:
Documentation, including mechanical test results, was provided demonstrating that the subject VERTEX™ Reconstruction System components are substantially equivalent to VERTEX® Reconstruction System components previously cleared in K042789 (SE 12/21/04). The labeling is identical to that cleared in K052734 (SE 10/21/05).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of a human figure with three heads, representing the department's focus on health and human well-being. The figure is composed of curved lines and has a modern, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place
Re: K053483
Memphis, Tennessee 38132
Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, KWP Dated: December 8, 2005 Received: December 15, 2005
Dear Dr. Treharne:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
2006
JAN 5
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.
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
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Page 2 - Richard W. Treharne, PhD
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ 1 _ of _ _ l _
December 2005
510(k) Number (if known):_KOS3483
VERTEX® Reconstruction System_________________________________________________________________________________________________________________________________________________ Device Name:
Indications for Use:
When intended to promote fusion of the occipitocervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or turnors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous along with 4.0mm and 4.5mm cortical), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
The use of the occipitocervical plate/rod requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-axial Screws/Connectors
The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLASTM Cable System used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) | |
|---|---|---|---|---|
| ---------------------------------------------- | --- | -------- | --------------------------------------------- | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General, Restorative, Office of Device Evaluation (ODE)
and Neurological Devices
| 510(k) Number | K053483 |
|---|---|
| --------------- | --------- |
N/A