(21 days)
Not Found
No
The summary describes a mechanical spinal fixation system made of metal components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The VERTEX® Reconstruction System is explicitly described as a device providing stabilization to promote fusion and aid in the treatment of various spinal conditions such as DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and tumors. These are therapeutic interventions designed to treat or alleviate a disease or condition.
No
The provided text describes the VERTEX® Reconstruction System as a posterior system of rods, hooks, screws, and connecting components used to promote fusion and provide stabilization in the spine following reduction of fracture/dislocation or trauma. It is an implantable medical device for treatment, not for diagnosis.
No
The device description explicitly lists various hardware components such as rods, hooks, screws, multi-axial screws, connecting components, and cables, all fabricated from medical grade titanium or titanium alloy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to provide stabilization and promote fusion of the spine. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device description details physical components like rods, hooks, screws, and cables made of medical-grade materials. These are all physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
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 occipitoccrvical 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 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.
The titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine,
Product codes
MNI, KWP
Device Description
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of 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 tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion.
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 allowed 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 the KEEL Plate to the system , to expand the use of the VERTEX® M6 Set Screws to include the occiput and to correct a clerical error related to the 4.0mm and 4.5mm cortical screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Occipitocervical spine, cervical spine, thoracic spine (Occiput-T3), occipitocervical junction, cervical spine, upper thoracic (C1-T3) spine, posterior cervical or thoracic spine.
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)
A risk analysis was provided demonstrating that the subject VERTEX® Reconstruction System components are substantially equivalent to VERTEX® pre-curved occipital plate/rod components previously cleared in K052402, and to the set screws cleared in K052180 and K042498.
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.
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
OCT 2 1 2005
VERTEX® Reconstruction System 510(k) Summary September 2005
| I. | Company: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132 |
|-----|----------------------|-------------------------------------------------------------------------------------|
| | Contact: | Richard W. Treharne
Sr. Vice President Regulatory Affairs
(901) 396-3133 |
| II. | Product Name: | VERTEX® Reconstruction System |
| | Classification Name: | Spinal Interlaminal Fixation Orthosis |
Regulation Number: Code:
Interlaminal Fixation ( Pedicle Screw Spinal System 888.3050, 888.3070 KWP, MNI
III. Description:
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of 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 tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion.
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 - NíTì). 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 allowed 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 the KEEL Plate to the system , to expand the use of the VERTEX® M6 Set Screws to include the occiput and to correct a clerical error related to the 4.0mm and 4.5mm cortical screws.
00005 :
1
IV Indications
When intended to promote fusion of the occipitoccrvical 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 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.
The 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:
A risk analysis was provided demonstrating that the subject VERTEX® Reconstruction System components are substantially equivalent to VERTEX® pre-curved occipital plate/rod components previously cleared in K052402, and to the set screws cleared in K052180 and K042498.
000C5.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
OCT 2 1 2005
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 Memphis, Tennessee 38132
Re: K052734
Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, KWP Dated: September 29, 2005 Received: September 30, 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, 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, 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
Page 2- Richard W. Treharne, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailing of substantial equivalence of your device to a legally premaired predicated 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 If you desire specific acries in 1940 (276-0120. Also, please note the regulation entitled, Colliaot the Office of Company of Company (21CFR Part 807.97). You may obtain Missuranting of Icrerchive to premantonibilities under the Act from the Division of Small other general informational on your response at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
September 2005
510(k) Number (if known): KOSZƏ3Y
VERTEX® Reconstruction System Device Name: _________________________________________________________________________________________________________________________________________________________________
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.
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 X (Part 21 CFR 801 Subpart D)
Ov
(2:
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DONOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological DevicesAND/OR
ne 7724
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