(37 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system composed of plates, rods, hooks, screws, and connectors. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The device's function is purely structural support for spinal fusion.
Yes
The device is intended to promote fusion and provide stabilization for various spinal conditions, indicating a therapeutic purpose.
No
The VERTEX Reconstruction System is described as a posterior system composed of various components (plates, rods, hooks, screws, etc.) intended to provide stabilization to promote fusion in the spine. It is a surgical implant used for treatment, not for diagnosing conditions.
No
The device description explicitly lists physical components such as plates, rods, hooks, screws, and cables, which are hardware implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The VERTEX Reconstruction System is described as a posterior system consisting of implants (plates, rods, hooks, screws, etc.) intended for surgical implantation to stabilize the spine and promote fusion. Its intended use is for treating various spinal conditions like DDD, spondylolisthesis, fracture, etc.
- Lack of IVD Characteristics: The text does not mention any analysis of biological specimens, diagnostic testing, or providing information about a patient's health based on such analysis.
Therefore, the VERTEX Reconstruction System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
KWP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), Occipitocervical junction, C1-T3, posterior cervical or thoracic spine
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)
Not Applicable; the system did not change. The surgical techniques were only updated to provide more detail. The overall implant process did not change.
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.
K003780, K062447, K070742, K082728, K083071, K090714, K091365
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
§ 888.3050 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.
0
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 | ||||||||||||||||||||||||
| Establishment | |||||||||||||||||||||||||
| Registration | |||||||||||||||||||||||||
| Number | 1030489 | ||||||||||||||||||||||||
| Name of contact | |||||||||||||||||||||||||
| person | Nicholas Tabrizi | ||||||||||||||||||||||||
| Date prepared | March 17, 2011 | ||||||||||||||||||||||||
| Name of device | |||||||||||||||||||||||||
| Trade or | |||||||||||||||||||||||||
| proprietary name | VERTEX® Reconstruction System | ||||||||||||||||||||||||
| Common or usual | |||||||||||||||||||||||||
| name | VERTEX SELECT® Reconstruction System | ||||||||||||||||||||||||
| Classification | |||||||||||||||||||||||||
| name | Spinal Interlaminal Fixation Orthosis | ||||||||||||||||||||||||
| Classification panel | Class II | ||||||||||||||||||||||||
| Regulation | 21 CFR 888.3050 | ||||||||||||||||||||||||
| Product Code(s) | KWP | ||||||||||||||||||||||||
| Legally marketed | |||||||||||||||||||||||||
| device(s) to which | |||||||||||||||||||||||||
| equivalence 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 techniques | ||||||||||||||||||||||||
| into two concise documents. | |||||||||||||||||||||||||
| Device description | 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 |
1
| 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. | |
| Intended use of the | |
| device | 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. | |
| Indications for use | 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. |
2
| 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 Surgical | |||
| Technique | Vertex Reconstruction System, K003780 | ||
| Modification to the Vertex Reconstruction | |||
| System, K0070742 | |||
| Vertex Reconstruction System, Vertex | |||
| Select Reconstruction System, K082728 | |||
| Vertex Reconstruction System, K083071 | |||
| Vertex Reconstruction System, Vertex | |||
| Select Reconstruction System, K090714 | |||
| Vertex Reconstruction System, Vertex | |||
| Select Reconstruction System, K091365 | |||
| Traverse™ OCT Spinal Fixation System, | |||
| K062447 | |||
| Surgical Technique | VERTEX SELECT® | ||
| Reconstruction System Posted | |||
| Screw Module Surgical | |||
| Technique | Modification to the Vertex Reconstruction | ||
| System, K0070742 | |||
| Vertex Reconstruction System, K083071 | |||
| PERFORMANCE DATA | |||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | |||
| EQUIVALENCE* | |||
| 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 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 |
3
provide more detail. The overall implant process did not change.
.
4
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
5
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
6
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_
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