(24 days)
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.
Occipitocervical Plate/Rod/Occipital Screws/Hooks: The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spinc. 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. The use of the occipitocervical plate/rod requires 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of 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 tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. The VERTEX® Reconstruction System is fabricated from medical grade titanium or titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with medical grade titanium or titanium alloy implants only. Do not use with stainless steel. The purpose of this submission was to add modified lateral connectors to the VERTEX® Reconstruction System.
This is a 510(k) premarket notification for a medical device (VERTEX® Reconstruction System), which focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness through a traditional clinical study with acceptance criteria and measured device performance.
Therefore, the provided document does not contain the information requested regarding acceptance criteria or a study proving the device meets them in the way a clinical trial or performance study would for a new device.
Here's why and what information is available:
- Type of Submission: This is a 510(k) submission. For 510(k)s, the primary goal is to show the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if there are different technological characteristics, they do not raise different questions of safety and effectiveness.
- Missing Information: The document does not describe:
- Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance.
- A study designed to measure the device's performance against such criteria.
- Sample sizes, data provenance, expert ground truth establishment, adjudication methods for a test set, MRMC studies, or standalone algorithm performance.
- Training set details for an algorithm, as this device is a mechanical implant, not an AI/software device.
- What is Present: The document states that "Documentation has been provided which demonstrates that the VERTEX® Reconstruction System is substantially equivalent to VERTEX® Reconstruction System that was previously cleared in K042524 and K003780." This is the "study" and "proof" in the context of a 510(k) – it's a comparison to predicates, not a performance evaluation against a set of criteria.
In summary, as this is a 510(k) for a mechanical spinal implant system, the requested information pertaining to acceptance criteria and a study demonstrating performance in the context of AI/software algorithm evaluation (like sensitivity, specificity, expert ground truth, sample sizes, etc.) is not applicable and is not present in the provided text. The "study" here is a substantial equivalence comparison to predicate devices, which is a regulatory pathway, not a performance measurement study in the typical sense.
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SEP 23 2005
Ko52376
VERTEX® Reconstruction System 510(k) Summary September 19, 2005
| I. | Company: | Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132(901) 396-3133 | ||
|---|---|---|---|---|
| Contact: | Richard W. Treharne, Ph.D.Senior Vice President, Regulatory Affairs | |||
| II. | Product Name: | VERTEX® Reconstruction System | ||
| Classification Name: | Spinal Interlaminal Fixation Orthosis, Pedicle ScrewSpinal System | |||
| Regulation Number: | 888.3050, 888.3070 | |||
| Code: | KWP, MNI |
Description: III.
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of 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 tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion.
The VERTEX® Reconstruction System is fabricated from medical grade titanium or titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with medical grade titanium or titanium alloy implants only. Do not use with stainless steel.
The purpose of this submission was to add modified lateral connectors to the VERTEX® Reconstruction System.
IV Indications
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
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radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), 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.
The use of the occipitocervical plate/rod requires 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
V. Substantial Equivalence:
Documentation has been provided which demonstrates that the VERTEX® Reconstruction System is substantially equivalent to VERTEX® Reconstruction System that was previously cleared in K042524 and K003780.
page 2 of 2
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
SEP 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K052376
K052370
Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI Dated: August 29, 2005 Received: August 30, 2005
Dear Dr. Treharne:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and nave determined the arreted predicate devices marketed in interstate for use stated in the enclosure) to legally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment answerings of the Federal Food. Drug commerce prior in May 28, 1970, the cities with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance who we proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approvine of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general negat You may, therefore, market the device, sucject to urements for annual registration, listing of
general controls provisions of the Act include required michrending and general controls provisions of the rect mendo requirements.
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 If your device is classified (see above) more more regulations affecting your device can
may be subject to such additional controls. Title 01 - 808 - 808 - 808 - 808 - 104 m may be subject to such additions. Existing major regaleto 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 899 be found in the Code of I cacial regarations, your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualice of a subscribe with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a determination that your as res by other Federal agencies. You must or any Federal statules and regulations administered of registration and listing (21 l
comply with all the Act's requirements, including, but not limited to: requirements as comply with all the Act Stequirements, more and manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Pactor); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, the electron forth in the quality systems (Q5) regulation (21-51-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Richard W. Treharne, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the same of a local at the samination of your device to a legal This letter will allow you to begin marketing your avince of your device of your device to a legally premarket notification. The PDA inding of substantial equice 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
rs to and the many of the 110 - All and 1400 - All any desse note the regul If you desire specific auvice for your do no no no a come note the regulation entitled, the regulation entitled, would obtain contact the Office of Compliance at (240) 270 - 1210 - 121 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21) - 1 the Division of Small "Misbranding by reference to prematics notification (the Act from the Division of Small)
other general information on your responsibilities under the Act from worker (800) 63 other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at their unnortlinges btml Manufacturers, International and Consumer Pisolation around consection of the new learner in the support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Metkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 _ of __ 1 __ 1 __
August 2005
510(k) Number (if known): K052376
VERTEX® Reconstruction System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
When intended to promote fusion of the occipitocervical 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.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spinc. 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.
The use of the occipitocervical plate/rod requires 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) | |
|---|---|---|---|---|
| ---------------------------------------------- | --- | -------- | --------------------------------------------- | -- |
(PLEASE SIGN BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Division of General, Restorative, and Neurological Devices
510(k) Number K052376
§ 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.