(90 days)
Not Found
No
The description focuses on the mechanical components and materials of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is described as a "Spinal Fixation System" intended to provide "immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of instabilities or deformities." This directly addresses medical conditions and aims to restore function, which aligns with the definition of a therapeutic device.
No.
The Endius Spinal Fixation System is described as a system for posterior lumbar fusion procedures, consisting of components like screws, rods, and plates, intended to provide immobilization and stabilization of spinal segments. It is a treatment device, not one that identifies or investigates the cause or nature of a disease.
No
The device description explicitly states it is a system manufactured from titanium and includes physical components like screws, rods, and plates. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Endius Spinal Fixation System is described as a system of screws, rods, plates, and accessory components made of titanium, intended for surgical implantation to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Its intended use is for treating various spinal conditions like degenerative disc disease, spondylolisthesis, fractures, deformities, tumors, and failed fusions.
- Lack of IVD Characteristics: There is no mention of this device being used to test samples from the body, analyze biological markers, or provide diagnostic information based on laboratory analysis. It is a physical implant used in a surgical procedure.
Therefore, the Endius Spinal Fixation System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Endius Spinal Fixation 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 the thoracic, lumbar, and sacral spine.
The Endius Spinal Fixation 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Endius Spinal Fixation System is also indicated for pedicle screw fixation for severe spondylolisthesis (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 obtained. Levels of fixation are L3-S1.
In addition, the Endius Spinal Fixation System, when not used with pedicle screws, is indicated for posterior hook and sacral screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previously failed fusion surgery.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNH, MNI
Device Description
The Endius Spinal Fixation 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; L3-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: Complies with ASTM F1717
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.
The Endius Spinal Fixation System is substantially equivalent to the TriFix Spinal System manufactured by Endius, Inc.
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
MAR 1 1 2002
page 1 of 3
ー ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...
Section 7 - 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted 7.1 in accordance with the requirements of SMDA 1990 and CFR 807.92 Statement
7.2 Endius, Inc. 23 West Bacon Street Submitter Plainville, MA. 02762
7.3 Gene DiPoto Company Vice President of Engineering Contact 508-643-0983 Ext. 104
| 7.4 | Proprietary Name: |
|---|---|
| Device | |
| Name | Endius Spinal Fixation System |
| 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) |
The Endius Spinal Fixation System is substantially equivalent to the TriFix 7.5 Spinal System manufactured by Endius, Inc. Predicate Legally Marketed Devices
1
KOI 4090
·
page 2 of 3
| 7.6
Device
Description | The Endius Spinal Fixation 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. |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.7
Device
Indications
and
Intended
Use | The Endius Spinal Fixation 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 the thoracic, lumbar,
and sacral spine.
The Endius Spinal Fixation 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 neurological
impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed
previous fusion (pseudarthrosis).
The Endius Spinal Fixation System is also indicated for pedicle screw fixation
for severe spondylolisthesis (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 obtained.
Levels of fixation are L3-S1.
In addition, the Endius Spinal Fixation System, when not used with pedicle
screws, is indicated for posterior hook and sacral screw fixation from T1 to the
ilium/sacrum. The non-pedicle screw indications are spondylolisthesis,
degenerative disc disease (discogenic back pain with degeneration of the disc
confirmed by history and radiographic studies), deformities (scoliosis, lordosis,
and kyphosis), tumor, fracture, and previously failed fusion surgery. |
The Endius Spinal Fixation System is substantially equivalent to the TriFix 7.8 Spinal System manufactured by Endius, Inc. Substantial Equivalence
2
page 3 of 3
Table of Substantial Equivalence 7.9
| Device Name | Endius Spinal Fixation System | TriFix 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 | Complies with ASTM | |
| F1717 | Complies with ASTM F1717 |
Applicant_
:
Date_
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or fabric. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2002
Mr. Gene DiPoto Vice President of Engineering Endius Incorporated 23 West Bacon Street Plainville, Massachusetts 02762
Re: K014090 Endius Spinal Fixation System Regulation Numbers: 888.3050 and 888.3070 Regulation Names: Spinal Interlaminal Fixation Orthosis; Spondylolisthesis Spinal Fixation Device System; and Pedicle Screw Spinal System Regulatory Classes: III Product Codes: KWP, MNH and MNI Dated: December 10, 2001 Received: December 11, 2001
Dear Mr. DiPoto:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Gene DiPoto
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 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Mark N. Millman
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
K014090 510(k) Number (if known):
Device Name: Endius Spinal Fixation System (Titanium)
Indications for Use:
The Endius Spinal Fixation 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 the thoracic, lumbar, and sacral spine.
The Endius Spinal Fixation 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Endius Spinal Fixation System is also indicated for pedicle screw fixation for severe spondylolisthesis (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 obtained. Levels of fixation are L3-S1.
In addition, the Endius Spinal Fixation System, when not used with pedicle screws, is indicated for posterior hook and sacral screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previously failed fusion surgery.
for Mark A. Milliken
sion Sign-Off vision of General, Restorative and Neurological Devices
510(k) Number K014090
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted July 1, 1998)
(Optional Format 3-10-98)