(41 days)
Not Found
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/ML.
No.
The indications for use describe the system as intended to provide immobilization and stabilization, which is a supportive and structural role rather than directly causing a therapeutic effect, and it is an adjunct to fusion.
No
Explanation: The device is a spinal system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description explicitly states it is a system manufactured from titanium and includes physical components like screws, rods, and plates.
Based on the provided information, the TriFix Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The description of the TriFix Spinal System clearly indicates it is a system of implants (screws, rods, plates) intended for surgical implantation into the spine to provide stabilization and immobilization.
- The intended use is for surgical treatment of spinal conditions. The indications for use describe conditions like degenerative disc disease, spondylolisthesis, fracture, scoliosis, kyphosis, tumor, and failed previous fusion. These are all conditions treated surgically, not diagnosed through in vitro testing of bodily fluids or tissues.
- The device description focuses on the physical components and material. It describes screws, rods, plates made of titanium, which are typical components of surgical implants.
- There is no mention of analyzing biological samples. The document does not describe any process involving the analysis of blood, urine, tissue, or any other specimen from the human body.
Therefore, the TriFix Spinal System is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TriFix Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.
The Tri-Fix Spinal System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The posterior Tri-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The posterior Tri-Fix System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with mateautins and of the disc confirmed by history and radiographic studies), deformities (scoliosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.
Product codes
MNI, MNH, KWP
Device Description
The Tri-Fix Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, plates, and accessory connection components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1, T1 to the ilium sacrum
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)
Biomechanical Test Results: Stiffness Range = within the range of ISOLA
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ISOLA Spinal System
Reference Device(s)
Not Found
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.
0
K011830 p/3
(JUL 2 ) 2001
Section 7 - 510(k) Summary of Safety and Effectiveness
7.1 This summary of 510(k) safety and effectiveness information is being submitted Statement in accordance with the requirements of SMDA 1990 and CFR 807.92
7.2 Endius, Inc. Submitter 23 West Bacon Street Plainville, MA. 02762
7.3 Susan Finneran Company Director RA Contact 508-643-0983 Ext. 114
7.4 Proprietary Name: Device Tri-Fix Spinal Fixation System Name Common Name: Pedicle Screw System , Non-pedicle spinal fixation system Classification Name: Spinal Pedicle Screw (MNI),Spinal Interlaminal fixation orthosis (KWP), Spondylolithesis Spinal Fixation Device System (MNH)
7.5 The TriFix Spinal System is substantially equivalent to the ISOLA Spinal Predicate System (DePuy, Acromed, Inc., Cleveland OH) for the indication of Legally Degenerative Disc Disease. Marketed Devices
1
Ko11830 p 3
The Tri-Fix Spinal System is a system that is intended to be used for posterior 7.6 Device lumbar fusion procedures. The system is manufactured from titanium which Description complies with ASTM F136. The components, which are included as part of the system, include screws, rods, plates, and accessory connection components. 7.7 The TriFix Spinal System is indicated for degenerative disc disease (defined as Device discogenic back pain with degeneration of the disc confirmed by history and Indications radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral and spine. Intended The Tri-Fix Spinal System is a pedicle screw system intended to provide Use 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The posterior Tri-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. The posterior Tri-Fix System, when not used with pedicle screws is indicated for hook, wire, and /or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
7.8 Substantial Equivalence
The TriFix Spinal System is substantially equivalent to the ISOLA Spinal System (DePuy, Acromed, Inc., Cleveland OH) for all indications.
2
风011830 03/3
Table of Substantial Equivalence 7.9
| Tri-Fix Spinal System | ISOLA Spinal System | |
|---|---|---|
| Indications for Use | See above | Identical |
| Materials | Titanium | Stainless Steel or Titanium |
| Product Labeling | Instructions for use and | |
| box labeling including | ||
| all of the necessary | ||
| warning statements | Instructions for use and box | |
| labeling including all of the | ||
| necessary warning statements | ||
| Packaging/ | ||
| Sterilization | Non-sterile, single use | |
| only | Non-sterile, single use only | |
| Biomechanical | ||
| Test Results | Stiffness Range= | |
| within the range of | ||
| ISOLA | Stiffness Range= | |
| Outside the range of TriFix |
Applicant
Date__________________________________________________________________________________________________________________________________________________________________________
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan Finneran Director Regulatory Affairs/ Clinical Sciences Endius, Inc. 23 West Bacon Street Plainville, Massachusetts 02762
JUL 2 3 2001
Re: K011830
Trade Name: Tri-Fix Spinal Fixation System Regulatory Class: Class III, Class II Regulatory Number: 888.3070, 888.3050, Product Code: MNI, MNH, KWP Dated: June 11, 2001 Received: June 12, 2001
Dear Ms. Finneran:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
4
Page 2 - Ms. Susan Finneran
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mrelellertop
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): KO( ( 3 0
Device Name: Tri-Fix Spinal Fixation System (Stainless Steel and Titanium)
Indications for Use:
The TriFix Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.
The Tri-Fix Spinal System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The posterior Tri-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The posterior Tri-Fix System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with mateautins and of the disc confirmed by history and radiographic studies), deformities (scoliosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98) (Posted July 1, 1998) Division of General, Restorative and Neurological Devices 510(k) Number