(120 days)
No
The document describes a mechanical spinal reconstruction system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended as an "adjunct to fusion" and provides "stabilisation to promote fusion" for various spinal conditions, indicating a therapeutic purpose.
No
The device is described as a "posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components," intended to provide stabilization to promote fusion. This description indicates it is an orthopedic implant for treatment, not a device used for diagnosis.
No
The device description explicitly lists various hardware components such as plates, rods, hooks, screws, and cables, all fabricated from medical-grade materials. There is no mention of software as the primary or sole component.
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 used to provide stabilization to promote fusion in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like plates, rods, hooks, and screws made of various metals. These are surgical implants.
- No mention of in vitro testing: There is no mention of analyzing samples (like blood, urine, or tissue) outside of the body, which is the hallmark of an in vitro diagnostic device.
- Anatomical Site: The device is used directly on the spine, an internal anatomical site.
Therefore, the VERTEX Reconstruction System is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
When intended as an adjunct to fusion in skeletally mature patients using allograft and/or autograft 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 prev10us 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 is 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 hist of the CD HORIZON® Spinal System indications of use
Product codes
KWP
Device Description
The VERTEX Reconstruction System is a posterior system, which IV. 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 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 Allov (Nitinol ~ NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. The posted screw connectors and some multi-axial screws contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
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)
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
The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components
Key Metrics
Not Found
Predicate Device(s)
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
JAN 1 6 2009
VERTEX® Reconstruction System 510(k) Summary
November 2008
| I. Company: | Medtronic Sofamor Danek USA
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Melisa Lansky, M.B.A. |
Proposed Proprietary Trade Name: VERTEX® Reconstruction System II.
- Classification Name(s): Spinal Interlaminal Fixation Orthosis; Class: II; Product III. Code(s): KWP and Regulation No.: 888.3050
- Description: The VERTEX Reconstruction System is a posterior system, which IV. 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.
Sr. Regulatory Affairs Specialist
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 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 Allov (Nitinol ~ NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. The posted screw connectors and some multi-axial screws 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 orthopedic and neurosurgical implants, none of the VERTEX Reconstruction System components should ever be reused under any circumstances.
V. Indications for Use:
When intended as an adjunct to fusion in skeletally mature patients using allograft and/or autograft 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
1
and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed prev10us 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 is 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 hist of the CD HORIZON® Spinal System indications of use
- VI Substantial Equivalence Documentation was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K042402 (SE 10/1/04), K042789 (SE 12/21/04), and K081297 (SE 6/11/08) The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components
C 2008 Medtronic Sofamor Danek
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Medironic Sofamor Danek c/o Ms Melisa Lansky Sr Regulatory Affairs Specialist 1800 Pyramid Place Memphis, TN 38132
K082728 Re
Trade/Device Name Veitex ® Select Reconstruction OCT System Regulation Number 21 CFR 888 3050 Regulation Name Spinal Interlaminal Fıxatıon Orthosis Regulatory Class Class II Product Code KWP Dated November 20, 2008 Received November 21, 2008
Dear Ms Lansky
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 pror 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, Insting 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
! 1: 11
3
Page 2 - Ms Melisa Lansky
forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electionic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometic's (OSB's) Division of Postmarket Surveillance at (240) 276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Mark N. Millerson
Mark N Melkerson Director Dıvısıon of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) K082728
Device Name VERTEX® Reconstruction System
Indications for Use
When intended as an adjunct to fusion in skeletally mature patients using allograft 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), spondylolusthesis, 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 occupitocervical junction and the cervical spine When used to treat these occipitocervical and cervical conditions, these screws are linuted to occupital fixation only The screws are not intended to be placed in the cervical spine
Occipitocervical constructs require briation to C2 and below Note Segmental fixation is recommended for these constructs
Hooks and Rods
The hooks and tods are also intended 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 TI-T3 The sciews are not untended 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 unset for a list of the CD HORIZON® Spinal System indications of પકર
Prescription Use X (Part 21 CFR 801 Subpart D) 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) | Division , "Contrative. |
| and Neur | |
| /K08272-V |
AND/OR