(89 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as aiding fusion and stabilization of the spine for various conditions, indicating a direct therapeutic action on the body.
No
Explanation: The VERTEX® Reconstruction System is a posterior stabilization system used for fusion of the spine, not for diagnosing conditions. It is an implantable device used to treat various spinal conditions, not to identify them.
No
The device description explicitly lists physical components such as plates, rods, hooks, screws, and cables, and describes their materials and intended use in surgical procedures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The VERTEX® Reconstruction System is described as a posterior system consisting of implants (plates, rods, hooks, screws, etc.) used for spinal fusion. These are surgically implanted devices.
- Intended Use: The intended use is to provide stabilization to promote fusion of the spine in skeletally mature patients with various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The text clearly describes a surgical implant system used for structural support and fusion within the body, which falls outside the scope of in vitro diagnostics.
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
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.
Connectors
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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
Product codes
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, 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 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
occipitocervical spine, cervical spine, and the 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)
Medtronic performed compression fatigue, static compression and static torsion on the subject tapered rods in accordance with ASTM 1717-12. Mechanical testing was not required for the subject pre-cut/pre-bent rods, threaded rods, dominoes, crosslinks or plates since the difference between them and the predicate devices were additional lengths and diameters which do not present a worst-case scenario. Non-clinical testing in the form of design verification and validation activities was performed on the subject devices to show equivalence to the previously listed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070742, K080805, K042789, K070742, K090714, K090714, K090714, K082728, K091365
Reference Device(s)
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.
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VERTEX® Reconstruction System 510(k) Summary January 29, 2013
FEB 2 5 2013
l. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis. TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Claire Evans Contact: Senior Requlatory Affairs Specialist
- Proprietary Trade Name: VERTEX® Reconstruction System II.
- III. Classification Name: Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050
- IV. Classification: Class II
- V. Product Codes: KWP
- VI. Product Description: The VERTEX® Reconstruction System is a posterior svstem, 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, 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 orthopaedic and neurosuraical implants,
1
none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.
VII. Indications: 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
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.
Connectors
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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
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-
Summary of Technological Characteristics: The purpose of this 510(k) is VIII. to add additional components to the VERTEX® Reconstruction System. The subject and predicate parts are identical in terms of material, indications for use, intended use, and performance specifications. The key differences between the subject and predicate devices are additional lengths, diameters and overall design profile.
K123656 -
IX. Identification of Legally Marketed Devices: The design features, materials and indications for use of the subject devices are substantially equivalent to predicate VERTEX® Reconstruction System devices for pre-cut/pre-bent (K070742, S.E. 09/14/2007 and K080805, S.E. 04/18/2008), tapered rods (K042789, S.E. 12/21/2004, K070742, S.E. 09/14/2007 and K090714, S.E. 04/17/2009), threaded rods (K090714, S.E. 04/17/2009), dominoes (K090714, S.E. 04/17/2009), crosslinks (K082728, S.E. 01/16/2009) and OC plates (K091365, S.E. 08/06/2009).
The labeling is identical to that cleared in K121191 (S.E. 06/29/12). -
Discussion of the Non-Clinical Testing: Medtronic performed compression X. fatique, static compression and static torsion on the subject tapered rods in accordance with ASTM 1717-12.
Mechanical testing was not required for the subject pre-cut/pre-bent rods, threaded rods, dominoes, crosslinks or plates since the difference between them and the predicate devices were additional lengths and diameters which do not present a worst-case scenario.
Non-clinical testing in the form of design verification and validation activities was performed on the subject devices to show equivalence to the previously listed predicate devices.
- XI. Conclusions: A risk analysis was completed for the changes incorporated into the subject devices. Based on the results and additional supporting documentation provided in this submission, the subject devices demonstrated substantial equivalence to the previously listed predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Letter dated: February 25, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated % Ms. Claire Evans Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K123656
Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: K WP Dated: November 27, 2012 Received: November 28, 2012
Dear Ms. Evans:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Ms. Claire Evans
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N.Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K123656
510(k) Number (if known):
Device Name: VERTEX® Reconstruction System
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
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.
Connectors
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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and 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)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123656