(71 days)
Not Found
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 a reconstruction system intended to promote fusion of the spine for various conditions, which directly addresses a medical condition and aims to restore or improve physiological function.
No
The device is described as a "Reconstruction System" and its intended use is to "promote fusion" and "provide stabilization" of the spine, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of physical components like plates, rods, hooks, screws, and connecting components made of medical grade materials. This indicates it is a hardware-based medical device, not software-only.
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 stabilizing the spine to promote fusion. This is a therapeutic device used in vivo (within the body), not a diagnostic device used in vitro (outside the body) to examine specimens.
- Device Description: The device description details physical components like plates, rods, hooks, and screws made of various medical-grade materials. These are all components of a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
The device is a spinal reconstruction system intended for surgical implantation.
N/A
Intended Use / Indications for Use
When intended to promote fusion 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 previous fusion and/or tumors. 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 (comma separated list FDA assigned to the subject device)
KWP
Device Description
The VERTEX SELECT® 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, thoracic spine (Occiput-T3, C1-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 changes proposed to the connectors: 1)increasing thread and drill depth of the set screw hole on the connector and 2) widening the tolerance on the rod slot diameter, as well as the changes to the multi-axial screw, do not require additional bench testing since neither presents a new worse case scenario. Therefore, the subject VERTEX® Reconstruction System connectors and multi-axial screw are safe and effective and perform as well as the predicate VERTEX ® Reconstruction System connectors and multi-axial screw.
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.
K090714, K082728, K083071, K042789
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
JUN 2 9 2012
510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | |||
|---|---|---|---|
| Name | Medtronic Sofamor Danek USA, Inc. | ||
| Address | 1800 Pyramid Place Memphis, TN 38132 | ||
| Phone number | 901-344-0804 / 901-344-1463 | ||
| Fax number | 901-346-9738 | ||
| Establishment | |||
| Registration | |||
| Number | 1030489 | ||
| Name of contact | |||
| person | Claire Evans / Nicholas Tabrizi | ||
| Date prepared | April 18, 2012 | ||
| Name of device | |||
| Trade or | |||
| proprietary name | VERTEX® Reconstruction System | ||
| Common or Usual | |||
| name | Metallic Orthopedic Plate, Rod and Screw | ||
| Classification | |||
| name | Spinal Interlaminal Fixation Orthosis, Single/Multiple Component | ||
| Metallic Bone Fixation Appliances and Accessories, Pedicle Screw | |||
| System | |||
| Classification | Class II | ||
| Regulation | 888.3050 | ||
| Product Code(s) | KWP | ||
| Legally marketed | |||
| device(s) to which | |||
| equivalence is claimed | 510(k) | ||
| Number | Title | Date | |
| Cleared | |||
| K090714 | VERTEX® Reconstruction System, | ||
| VERTEX SELECT® Reconstruction | |||
| System | 4/17/09 | ||
| K082728 | VERTEX® Reconstruction System, | ||
| VERTEX SELECT® Reconstruction | |||
| System | 1/16/09 | ||
| K083071 | VERTEX® Reconstruction System | 11/14/08 | |
| K042789 | VERTEX® Reconstruction System | 12/21/04 | |
| Reason for 510(k) | |||
| submission | The purpose of this 510(k) is to modify the connectors and add a 5.5mm | ||
| multi-axial screw to the VERTEX® SELECT Reconstruction System. | |||
| Two changes are being proposed to the connectors: (1) The thread | |||
| depth and drill depth of the set screw threaded hole on the connector is | |||
| increasing and (2) the tolerance on the rod slot diameter will be | |||
| widened. |
1
| Device description | The VERTEX SELECT® 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. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use of the
device | When intended to promote fusion 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 previous fusion and/or tumors. |
| 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. |
.
2
| 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. | |||
| Summary of the technological characteristics of the device compared to the predicate device | The primary change from the predicate devices for the connectors is the minimum thread depth and maximum drill depths are increased on the subject device. In relation with the depth changes, the tolerance on the wide slot diameter was widened to accommodate the increase in thread depth and drill depth. |
The primary change from the predicate devices for the multi-axial screw is the diameter is being increased from 4.5mm to 5.5mm on the subject device. | | |
| PERFORMANCE DATA | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | | | |
| Performance Test Summary-New Device | | | |
| Characteristic | Standard/Test/FDA Guidance | Results Summary | |
| N/A | N/A | N/A | |
| Comparative Performance Information Summary | | | |
| Characteristic | Requirement | New Device | Predicate Device |
| N/A | N/A | N/A | N/A |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | |
| Not Applicable | | | |
·
3
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The changes proposed to the connectors: 1)increasing thread and drill depth of the set screw hole on the connector and 2) widening the tolerance on the rod slot diameter, as well as the changes to the multi-axial screw, do not require additional bench testing since neither presents a new worse case scenario. Therefore, the subject VERTEX® Reconstruction System connectors and multi-axial screw are safe and effective and perform as well as the predicate VERTEX ® Reconstruction System connectors and multi-axial screw.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
JUN 2 9 2012
Medtronic Sofamor Danek USA, Inc. % Ms. Claire Evans Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K121191
Trade/Device Name: Vertex® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: April 18, 2012 Received: April 19, 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 addition. Trease noter, u, 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.
5
Page 2- Ms. Claire Evans
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For Pete D'Amico
Mark N. M Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K12 11 91
Device Name: VERTEX® Reconstruction System
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 usinq 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 | X |
|---|---|
| ------------------ | --- |
Over-The-Counter Use AND/OR
4 CFR 907 Subpart C)
(Part 21 CFR 801 Subpart D)
(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 of Surgical, Orthopedic,
and Restorative Devices
(s) Number K12191