(90 days)
Not Found
No
The 510(k) summary describes a mechanical spinal reconstruction system consisting of plates, rods, hooks, screws, and connectors. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies are mechanical testing, not related to AI/ML performance metrics.
Yes
The device is a medical implant intended to provide stabilization to promote fusion, treat conditions like DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and tumors, which are all therapeutic interventions.
No
Explanation: The VERTEX® Reconstruction System is described as a posterior system composed of implants (plates, rods, hooks, screws, etc.) intended to provide stabilization to promote fusion in the spine. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists various hardware components such as plates, rods, hooks, screws, and connecting components, and discusses their materials and compatibility. 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 stabilize the spine during fusion procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the system (plates, rods, screws, etc.) which are implanted into the body. IVD devices are used to examine specimens taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
The device is a surgical implant intended for structural support and stabilization within the body.
N/A
Intended Use / 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 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 list of the CD HORIZON® Spinal System indications of use.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The VERTEX® 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 purpose of this submission is to add an adjustable Occipitocervical plate to the system. 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 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 orthopedic 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, thoracic spine (Occiput-T3), occipitocervical junction, upper thoracic (C1-T3), T1-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (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.
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K091365 Page 1 of 2
VERTEX® Reconstruction System 510(k) Summary
AUG 0 6 2009
August 2009
Medtronic Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
| Contact: | Melisa Lansky, M.B.A. |
|---|---|
| Sr. Regulatory Affairs Specialist |
- Proposed Proprietary Trade Name: VERTEX® Reconstruction System II.
- III. Classification Name(s): Spinal Interlaminal Fixation Orthosis; Class: II; Product Code(s): K WP and Regulation No .: 888.3050
- IV. Description: The VERTEX® 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 purpose of this submission is to add an adjustable Occipitocervical plate to the system.
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 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 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 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.
1
K091365 page 2 of 2
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 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 list of the CD HORIZON® Spinal System indications of use.
- Substantial Equivalence: Documentation was provided demonstrating that the VI. VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K080805 (S.E. 4/18/08), K082728 (S.E. 1/16/09), and K052734 (S.E. 10/21/05). 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,
© 2009 Medtronic Sofamor Danek
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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G605 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA % Ms. Melisa Lansky, M.B.A Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
AUG 0 6 2009
Re: K091365
Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: · May 6, 2009 Received: May 8, 2009
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 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 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); 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.
3
Page 2 - Ms. Melisa Lansky, M.B.A
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
VERTEX® Reconstruction System Device Name:__________________________________________________________________________________________________________________________________________________________________
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 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 TI-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 X (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)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ K0 91365