(37 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.
When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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 Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, 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.
Occipitocervical constructs require 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 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.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
The VERTEX SELECT Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, 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 ATLAS® 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, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. The VERTEX Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
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 document.
As with all orthopaedic and neurosurgical implants, none of the VERTEX Reconstruction System components should ever be reused under any circumstances.
This document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal interlaminal fixation orthosis. It's a regulatory submission affirming substantial equivalence to previously cleared devices, not a study reporting on the device's performance in detail against specific acceptance criteria. Therefore, the information requested about acceptance criteria and study details for device performance is largely not present in this document.
However, based on the context of a 510(k) submission for a spinal implant, we can infer some general aspects.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria nor does it report specific device performance data in a quantitative manner as typically found in clinical studies or performance testing reports. This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, which implies that the new device meets the same safety and effectiveness standards as the predicate devices.
The "PERFORMANCE DATA" section states:
- "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*": "N/A" for characteristic, standard/test/FDA guidance, and results summary.
- "Comparative Performance Information Summary": "N/A" for characteristic, requirement, new device, and predicate device.
- "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION": "Not Applicable"
- "CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA": "Not Applicable; the system did not change. The surgical techniques were only updated to provide more detail. The overall implant process did not change."
This explicitly states that no new performance data (clinical or non-clinical) was generated or submitted for this particular 510(k). The purpose of this submission was to consolidate several cleared surgical techniques into two concise documents, implying that the device itself, and its performance characteristics, are considered unchanged from previously cleared versions.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
As indicated above, there was no new test set used for a performance study described in this 510(k) submission. Therefore, information regarding sample size, data provenance, retrospective/prospective nature, or country of origin is not available in this document.
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)
Since there was no new test set or clinical study conducted, there's no information on experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new test set or study was performed.
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 a submission for a spinal implant system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis would be part of this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new performance study generating ground truth was described.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device.
Summary of what can be inferred from the document:
The VERTEXT® Reconstruction System is a spinal implant system. This 510(k) submission (K110522) by Medtronic Sofamor Danek USA, Inc. primarily served to:
- Consolidate existing surgical techniques for the device into updated documentation.
- Affirm that the device itself and its indications for use remain substantially equivalent to previously cleared predicate devices (listed in the document, e.g., K003780, K062447, etc.).
The "study" that proves the device meets acceptance criteria referred to by the applicant (Medtronic) is the accumulated body of evidence and prior clearances for the predicate devices and earlier versions of the VERTEX® Reconstruction System. This 510(k) is essentially a declaration that the changes (consolidation of surgical techniques) do not alter the substantial equivalence to those previously cleared devices, and therefore, no new performance data or clinical studies were deemed necessary by the FDA.
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APR - 1 20i1
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | Medtronic Sofamor Danek USA, Inc. | ||||||||||||||||||||||||
| Address | 2600 Pyramid Place Memphis, TN 38132 | ||||||||||||||||||||||||
| Phone number | 901-344-1463 | ||||||||||||||||||||||||
| Fax number | 901-346-9738 | ||||||||||||||||||||||||
| EstablishmentRegistrationNumber | 1030489 | ||||||||||||||||||||||||
| Name of contactperson | Nicholas Tabrizi | ||||||||||||||||||||||||
| Date prepared | March 17, 2011 | ||||||||||||||||||||||||
| Name of device | |||||||||||||||||||||||||
| Trade orproprietary name | VERTEX® Reconstruction System | ||||||||||||||||||||||||
| Common or usualname | VERTEX SELECT® Reconstruction System | ||||||||||||||||||||||||
| Classificationname | Spinal Interlaminal Fixation Orthosis | ||||||||||||||||||||||||
| Classification panel | Class II | ||||||||||||||||||||||||
| Regulation | 21 CFR 888.3050 | ||||||||||||||||||||||||
| Product Code(s) | KWP | ||||||||||||||||||||||||
| Legally marketeddevice(s) to whichequivalence is claimed | 510(k) Number Title Date Cleared K003780 Vertex Reconstruction System 9/28/01 K062447 Traverse OCT Spinal Fixation System 10/15/07 K070742 Modification to Vertex Reconstruction System 9/14/07 K082728 Vertex Reconstruction System, Vertex Select Reconstruction System 1/16/09 K083071 Vertex Reconstruction System 11/14/08 K090714 Vertex Reconstruction System, Vertex Select Reconstruction System 4/17/09 K091365 Vertex Reconstruction System, Vertex Select Reconstruction System 8/6/09 | ||||||||||||||||||||||||
| Reason for 510(k)submission | The purpose of this 510(k) is to consolidate several cleared surgical techniquesinto two concise documents. | ||||||||||||||||||||||||
| Device description | The VERTEX SELECT Reconstruction System is a posterior system, whichconsists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to therod in a variety of configurations, with each construct being tailor-made for theindividual case. Titanium ATLAS® cable may be used with this system at the |
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| surgeon's discretion. See the package inserts of both of those systems forlabeling limitations. | |
|---|---|
| The VERTEX Reconstruction System is fabricated from medical grade titanium,medical grade titanium alloy, and medical grade cobalt chromium. Medicalgrade titanium, medical grade titanium alloy, and/or medical grade cobaltchromium may be used together. Never use titanium, titanium alloy, and/orcobalt chromium with stainless steel in the same construct. The VERTEXReconstruction System includes a retaining ring for the multi-axial screw madeof Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible withtitanium, titanium alloy, and cobalt chromium implants only. Some componentscontain elastomeric stakes made of silicone adhesive commonly used inimplantable medical devices. Do not use with stainless steel.To achieve best results, do not use any of the VERTEX Reconstruction Systemimplant components with components from any other system or manufacturerunless specifically labeled to do so in this or another MEDTRONIC document.As with all orthopaedic and neurosurgical implants, none of the VERTEXReconstruction System components should ever be reused under anycircumstances. | |
| Intended use of thedevice | When intended to promote fusion of the occipitocervical spine, cervical spine,and the thoracic spine, (Occiput-T3), the VERTEX Reconstruction System isindicated for the following: DDD (neck pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies),spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusionand/or tumors. |
| Indications for use | When intended as an adjunct to fusion of the occipitocervical spine, cervicalspine, and the thoracic spine, (Occiput-T3), the VERTEX® ReconstructionSystem is indicated for skeletally mature patients using allograft and/orautograft for the following:DDD (neck pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies), spondylolisthesis, spinal stenosis, fracture,dislocation, failed previous fusion and/or tumors. |
| Occipitocervical Components: Plate Rod/Plates/Rods/OccipitalScrews/Hooks | |
| The occipitocervical plate rods, plates, rods, occipital screws, and hooks areintended to provide stabilization to promote fusion following reduction offracture/dislocation or trauma in the occipitocervical junction and the cervicalspine. When used to treat these occipitocervical and cervical conditions, thesescrews are limited to occipital fixation only. The screws are not intended to beplaced in the cervical spine. | |
| Occipitocervical constructs require bilateral fixation to C2 and below.Note: Segmental fixation is recommended for these constructs.Hooks and RodsThe hooks and rods are also intended to provide stabilization to promote fusionfollowing reduction of fracture/dislocation or trauma in the cervical/upperthoracic (C1-T3) spine. | |
| Multi-axial Screws/ConnectorsThe use of multi-axial screws are limited to placement in T1-T3. The screwsare not intended to be placed in the cervical spine.Titanium ATLAS® Cable System to be used with the VERTEX® ReconstructionSystem allows for cable attachment to the posterior cervical or thoracic spine. |
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| In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use. | |||
|---|---|---|---|
| Summary of the technological characteristics of the device compared to the predicate device | |||
| Characteristic | New Device | Predicate [Device Name][510(k) number] | |
| Surgical Technique | VERTEX SELECT®Reconstruction System SurgicalTechnique | Vertex Reconstruction System, K003780Modification to the Vertex ReconstructionSystem, K0070742Vertex Reconstruction System, VertexSelect Reconstruction System, K082728Vertex Reconstruction System, K083071Vertex Reconstruction System, VertexSelect Reconstruction System, K090714Vertex Reconstruction System, VertexSelect Reconstruction System, K091365Traverse™ OCT Spinal Fixation System,K062447 | |
| Surgical Technique | VERTEX SELECT®Reconstruction System PostedScrew Module SurgicalTechnique | Modification to the Vertex ReconstructionSystem, K0070742Vertex Reconstruction System, K083071 | |
| PERFORMANCE DATA | |||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE* | |||
| Performance Test Summary-New Device | |||
| Characteristic | Standard/Test/FDA Guidance | Results Summary | |
| N/A | N/A | N/A | |
| Comparative Performance Information Summary | |||
| Characteristic | Requirement | New Device | Predicate Device |
| N/A | N/A | N/A | N/A |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION | |||
| Not Applicable | |||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |||
| Not Applicable; the system did not change. The surgical techniques were only updated to |
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provide more detail. The overall implant process did not change.
.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA. Inc. % Mr. Nicholas Tabrizi Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
APR - 1 2011
Re: K110522
Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: March 21, 2011 Received: March 22, 2011
Dear Mr. Tabrizi:
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
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Page 2 - Mr. Nicholas Tabrizi
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Aling B. nh
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K110522
Device Name: VERTEX® Reconstruction System
Indications for Use:
When intended as an adjunct to fusion of the occipitocervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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 Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plates, rods, occipital screws, 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.
Occipitocervical constructs require 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 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.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
Prescription Use × (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)
Division Sign-Off) on of Surgical, Orthopedic, and Restorative Devices
K110522 510(k) Number_
Pg 1 of 1
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.