(87 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to promote fusion of spinal segments and provide stabilization, which are therapeutic actions.
No
The device is described as a spinal fixation system intended to promote fusion and provide stabilization. It is a surgical implant, not a tool for diagnosing medical conditions.
No
The device description explicitly states it is a "posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, plates and connecting components," all of which are physical hardware components.
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™ OCT Spinal Fixation System is described as a system of rods, hooks, screws, plates, and connecting components intended for the immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical implant, not a device used for testing biological samples.
- Intended Use: The intended use clearly states that the system is used to promote fusion of the occipitocervical and thoracic spine for various conditions like DDD, spondylolisthesis, fracture, etc. This is a therapeutic and structural purpose, not a diagnostic one.
The device is a surgical implant used in vivo (within the body) for structural support and stabilization, which is fundamentally different from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE™ OCT 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.
Occipitocervical Plate/Rod/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 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 plates and rods requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks
The hooks 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 of TI-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable used with the TRAVERSE™ OCT 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™ OCT Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine.
The TRAVERSE™ OCT Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, plates 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™ OCT Spinal Fixation System is fabricated from medical grade titanium alloy. Never use titanium alloy with stainless steel in the same construct. The TRAVERSE™ OCT Spinal Fixation System also includes a retaining ring for the multi-axial screws made of Shape Memory Alloy (Nitinol-NiTi). Shape Memory Alloy is compatible with titanium alloy. The offset connectors and multi-axial screw saddle contain elastomeric stakes made of silicone adhesive, and the occipital plates contain nickel-cobalt-chromium-molybdenum alloy coil springs. These materials are 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
occipital, cervical and/or upper thoracic spine, Occiput-T3, C1-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)
Mechanical testing was provided demonstrating that the TRAVERSE™ OCT Spinal Fixation System is substantially equivalent to other commercially available posterior occipitocervical fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System (K052402, SE 09/23/05; K052734, SE 10/21/05). The results of the testing performed for the TRAVERSE™ OCT Spinal Fixation System occipital components were equivalent to or better than the testing performed for the VERTEX® Reconstruction System occipital 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.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
TRAVERSE™ OCT Spinal Fixation System 510(k) Summary
I. Company:
December 2006 K062879 Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
DEC 2 2 2 2 2 2
Contact:
Christine Scifert Group Director, Regulatory Affairs
Proposed Proprietary Trade Name: TRAVERSE™ OCT Spinal Fixation System II.
- III. Classification Name(s): Spinal Interlaminal Fixation Orthosis: Spinal Intervertebral Body 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: VERTEX® Reconstruction System (K052402/K052734)
- V. Description: The TRAVERSE™ OCT Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine.
The TRAVERSE™ OCT Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, plates 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™ OCT Spinal Fixation System is fabricated from medical grade titanium alloy. Never use titanium alloy with stainless steel in the same construct. The TRAVERSE™ OCT Spinal Fixation System also includes a retaining ring for the multi-axial screws made of Shape Memory Alloy (Nitinol-NiTi). Shape Memory Alloy is compatible with titanium alloy. The offset connectors and multi-axial screw saddle contain elastomeric stakes made of silicone adhesive, and the occipital plates contain nickel-cobalt-chromium-molybdenum alloy coil springs. These materials are commonly used in implantable medical devices. Do not use with stainless steel.
- VI. Indications for Use: When intended to promote fusion of the occipitocervical spine, the cervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE™ OCT 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.
Occipitocervical Plate/Rod/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
1
K0622879
Page 2 of 2
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 plates and rods requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks
The hooks 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 of TI-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable used with the TRAVERSE™ OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
- VII. Substantial Equivalence: Mechanical testing was provided demonstrating that the TRAVERSE™ OCT Spinal Fixation System is substantially equivalent to other commercially available posterior occipitocervical fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System (K052402, SE 09/23/05; K052734, SE 10/21/05). The results of the testing performed for the TRAVERSE™ OCT Spinal Fixation System occipital components were equivalent to or better than the testing performed for the VERTEX® Reconstruction System occipital components.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Sofamor Danek % Mr. Edward S. Chin, D.Ph., MBA Group Director, Regulatory and Clinical Affairs 1800 Pyramid Place Memphis, Tennessee 38132
DEC 2 2 2006
Re: K062879
Trade/Device Name: TRAVERSE™ OCT Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, KWP Dated: September 22, 2006 Received: September 26, 2006
Dear Mr. Chin:
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. Edward S. Chin, D.Ph., MBA
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lot notification. The FDA finding of substantial equivalence of your device to a legally promated 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,
Barbara Buell
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
Page 1 _ of _ 1 _
December 2006
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
TRAVERSETM OCT Spinal Fixation System Device Name:
Indications for Use
When intended to promote fusion of the occipitocervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE™ OCT 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.
Occipitocervical Plate/Rod/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 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 plates and rods requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks
The hooks 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 of TI-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable used with the TRAVERSE™ OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
Prescription Use X (Part 21 CFR 801 Subpart D) 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) |
|---|
| (Division Offic |
AND/OR
Division of Restorative,
and Neurological Devices
510(k) Number K062874