(30 days)
Not Found
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended to "provide stabilization to promote fusion following reduction of fracture/dislocation or trauma." This clearly indicates its role in treating a medical condition and restoring health.
No
The VERTEX® Reconstruction System is described as a posterior system of implants (plates, rods, hooks, screws) intended to provide stabilization to promote fusion in the spine, particularly for conditions like DDD, spondylolisthesis, spinal stenosis, and fractures. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists various physical components made of medical-grade materials (plates, rods, hooks, screws, etc.), indicating it is a hardware-based medical device.
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 for stabilizing the spine to promote fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the system (plates, rods, hooks, screws, etc.) 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.
- Performance Studies: The performance studies mentioned are mechanical testing, which is relevant for the structural integrity of an implant, not the diagnostic accuracy of a test.
In summary, the VERTEX® Reconstruction System is a surgical implant designed for spinal stabilization, not a device used to perform diagnostic tests on biological samples.
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 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 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, cervical/upper thoracic (C1-T3) spine, 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)
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.
K003780, K042789, K052376, K053483, K014296
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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '090714'. The numbers are written in a slightly irregular style, but they are still legible.
VERTEX® Reconstruction System 510(k) Summary
March 2009
Sr. Regulatory Affairs Specialist
| 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. |
- II. Proposed Proprietary Trade Name: VERTEX® Reconstruction System
- 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 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.
page 1 of 2
1
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 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.
- 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 K003780 (S.E. 9/28/01), K042789 (S.E. 12/21/04), K052376 (S.E. 9/26/05), and K053483 (S.E. 1/15/06) and in CD HORIZON® Spinal System K014296 (S.E. 12/10/02). 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 2009 Medtronic Sofamor Danek
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Sofamor Danek, USA % Ms. Melisa Lanksy, M.B.A Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
APR 1 7 2009
Re: K090714
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: March 17, 2009 Received: March 18, 2009
Dear Ms. Lanksy:
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 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 Lanksy, M.B.A
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
Barbare buend
Mark N. Melke Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2090714
510(k) Number (if known):
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 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.
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)
baularo Varehuntofa, mkn
(Division Sign-On)
Division of General, Restorative,
and Neurological Devices
510(k) Number
page 1 of 1 K090714