(295 days)
Not Found
Not Found
No
The summary describes a mechanical spinal reconstruction system made of standard medical-grade materials. There is no mention of software, algorithms, image processing, AI, ML, or performance studies related to such technologies.
Yes.
The device is intended to promote fusion of the cervical and thoracic spine and is indicated for conditions like DDD, spondylolisthesis, spinal stenosis, and fracture, directly treating a medical condition.
No.
The device is a surgical implant intended to promote spinal fusion and stability, not to diagnose a condition.
No
The device description explicitly states it consists of physical components like rods, hooks, screws, and cables, fabricated from medical-grade titanium and Nitinol. It is a hardware-based implant system.
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 for spinal fusion and stabilization in the cervical and thoracic spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the implant system (rods, hooks, screws, cables) and the materials they are made from. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
The device is a surgical implant used to treat specific spinal conditions, not to diagnose them.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-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.
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/Lateral Connectors
The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial 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.
Product codes
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 described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol -- NiTi) as described by ASTM F2063. Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Medtronic Sofamor Danek expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. 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 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
cervical spine, thoracic spine, C1-T3
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)
Mechanical test data was provided in support of this notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
CONFIDENTIAL
K003780
10F2
VERTEXTM Reconstruction System 510(k) Summary (K003780) July 2001
| I. Company: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
(901) 396-3133 |
|----------------------|-------------------------------------------------------------------------------------------------------|
| II. Product Name: | VERTEX™ Reconstruction System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis |
Description: III.
SEP 2 8 2001
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 described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol -- NiTi) as described by ASTM F2063. Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Medtronic Sofamor Danek expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. 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 orthopaedic and neurosurgical implants, none of the VERTEX™ Reconstruction System components should ever be reused under any circumstances.
1/2
1
CONFIDENTIAL
Indications IV
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEXTM 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.
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/Lateral Connectors
The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial 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.
Substantial Equivalence: V.
The VERTEX™ Reconstruction System was claimed to be substantially equivalent to other commercially marketed systems.
Mechanical test data was provided in support of this notification.
20F
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2001
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K003780
Trade/Device Name: VERTEX™ Reconstruction System Regulation Number: 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: KWP Dated: June 10, 2001 Received: July 12, 2001
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) I his letter will and in yours finding of substantial equivalence of your device to a legally premaince notificated on " 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Fall States of Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 - 4 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision 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/dsma/dsmamain.html
Sincerely yours,
to Mark N Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1 July 2001
K003780 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
VERTEXTM Reconstruction System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-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.
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/Lateral Connectors
The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format
1-2-96)
Mark N. Melkerson
ivision Sign-( General, Restorative Neurological Devices K003780
510(k) Number -