(419 days)
Not Found
No
The summary describes a mechanical spinal fixation system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
This device is intended to promote fusion of the cervical and thoracic spine, treat various spinal conditions (like DDD, spondylolisthesis, fracture), and provide stabilization. These are all therapeutic actions aimed at treating a disease or injury.
No
The device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is a surgical implant, not a tool for diagnosis.
No
The device description explicitly states it consists of physical components like rods, hooks, screws, and connecting components fabricated from medical grade metals. It is a hardware-based spinal fixation system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The TRAVERSE™ Spinal Fixation System is described as a system of implants (rods, hooks, screws, cables) intended to be surgically implanted into the spine to provide immobilization and stabilization.
- Intended Use: The intended use is to promote fusion of the cervical and thoracic spine for various conditions. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
The description clearly indicates a device that is physically implanted into the body for structural support and stabilization, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSE™ Spinal Fixation 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.
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.
Screws/Connectors
The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.
Screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
Product codes (comma separated list FDA assigned to the subject device)
KWP,MNI
Device Description
The TRAVERSE™ Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine.
The TRAVERSE™ Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, 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 systems for labeling limitations.
The TRAVERSE™ Spinal Fixation System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, medical grade titanium alloy and/or medical grade cobalt-chromium-molybdenum allov may be used together. Never use titanium alloy and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct. Lastly, the offset connectors contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical and/or upper thoracic spine (C1-T3), cervical/upper thoracic (C1-T3) spine, T1-T3
Indicated Patient Age Range
Not Found
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)
Performance bench testing performed for the TRAVERSE™ Spinal Fixation System includes compression fatigue, static compression, and static torsion. The purpose of this testing was to support substantial equivalence to the aforementioned GALAXY™ 3.2 Spinal System. The results of the testing performed on the TRAVERSE™ Spinal Fixation System were equivalent or better than the commercially available GALAXY™ 3.2 Spinal System.
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.
0
Page 1 of 2
TRAVERSE™ Spinal Fixation System 510(k) Summary - K062447
CCT 1 5 2007
September 2007
| I. | Company: | Medtronic Sofamor Danek USA |
|---|---|---|
| 1800 Pyramid Place | ||
| Memphis, Tennessee 38132 | ||
| Telephone: (901) 396-3133 | ||
| Fax: (901) 346-9738 | ||
| Contact: | Raphael McInnis |
Regulatory Affairs Specialist
II. Proposed Proprietary Trade Name: TRAVERSE™ Spinal Fixation System
- Classification Name(s): Spinal Interlaminal Fixation Orthosis; Spinal Intervertebral Body III. Fixation Orthosis; Pedicle Screw Spinal System; Orthosis, Spinal Pedicle Fixation, for Degenerative Disc Disease; Class: II; Product Code(s): KWP,MNI; and Regulation No .: 888.3050 and 888.3070
- IV. Legally Marketed Devices: GALAXY™ 3.2 Spinal System (K043020)
- V. Description: The TRAVERSE™ Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine.
The TRAVERSE™ Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, 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 systems for labeling limitations.
The TRAVERSE™ Spinal Fixation System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, medical grade titanium alloy and/or medical grade cobalt-chromium-molybdenum allov may be used together. Never use titanium alloy and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct. Lastly, the offset connectors contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
- VI. Indications for Use: When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSE™ Spinal Fixation 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.
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.
1
Screws/Connectors
The use of screws is limited to placement in T1-T3 only. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
- VII. Substantial Equivalence: The TRAVERSE™ Spinal Fixation System is substantially equivalent to the GALAXY™ 3.2 Spinal System (K043020, SE 01/07/05). Performance bench testing performed for the TRAVERSE™ Spinal Fixation System includes compression fatigue, static compression, and static torsion. The purpose of this testing was to support substantial equivalence to the aforementioned GALAXY™ 3.2 Spinal System. The results of the testing performed on the TRAVERSE™ Spinal Fixation System were equivalent or better than the commercially available GALAXY™ 3.2 Spinal System.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2007
Medtronic, Inc. c/o Mr. Raphael McInnis Regulatory Affairs Specialist 1800 Pyramid Place Memphis, TN 38132
Re: K062447
Trade/Device Name: TRAVERSE™ Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI Dated: September 28, 2007 Received: October 1, 2007
Dear Mr. McInnis:
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 such 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); 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 - Mr. Raphael McInnis
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jarlau BuchnD
MLN. M. W.
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
510(k) Number (if known): K062447
Device Name: TRAVERSE™ Spinal Fixation System
Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSETM Spinal Fixation 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.
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.
Screws/Connectors
The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.
Screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
AND/OR Prescription Use X Over-The-Counter Use (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)
Aubare Buchan Johnson
and Neurological Devices
510(k) Number_K062447