(90 days)
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 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.
The provided text describes the Endius Spinal Fixation System and its substantial equivalence to a predicate device, the TriFix Spinal System. The evidence for meeting acceptance criteria primarily relies on biomechanical test results and comparison to the predicate device.
Here's a breakdown based on the information provided:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical Testing Compliance | Complies with ASTM F1717 |
| Indications for Use | Matches the predicate device (TriFix Spinal System) |
| Materials | Titanium (Predicate uses Stainless Steel or Titanium) |
| Product Labeling | Instructions for use and box labeling including all necessary warning statements (Identical to predicate) |
| Packaging/Sterilization | Non-sterile, single use only (Identical to predicate) |
Note: The FDA's substantial equivalence determination implies that the Endius Spinal Fixation System performs as safely and effectively as the legally marketed predicate device for its intended use. The primary 'study' presented is the comparison to the predicate and the biomechanical testing.
Study Details for Demonstrating Acceptance Criteria
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated for the biomechanical tests.
- Data Provenance: Not explicitly stated for specific test samples. However, the study involved a comparison against a predicate device, the TriFix Spinal System, also manufactured by Endius, Inc. The biomechanical testing compliance to ASTM F1717 refers to a standardized test, not a clinical trial withpatient data from specific countries.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable in the context of this submission. The "ground truth" for the device's performance in this filing is established through compliance with an industry standard (ASTM F1717) for biomechanical testing and comparison to a legally marketed predicate device. Clinical experts are not mentioned as being involved in establishing ground truth for the device's technical specifications or performance as required in this 510(k) summary.
4. Adjudication Method
- Adjudication Method: Not applicable. This submission relies on standardized testing and direct comparison to a predicate device, not on expert adjudication of clinical outcomes or images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed for this device as described in the provided text. This device is a spinal fixation system, not an AI/imaging diagnostic tool where such studies are common.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No, a standalone (algorithm only) performance study was not mentioned or performed. This device is a physical medical implant, not a software algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for demonstrating the device's meeting of acceptance criteria is based on:
- Biomechanical Test Results: Compliance with the ASTM F1717 standard for spinal implant constructs.
- Predicate Device Comparison: The established safety and effectiveness of the legally marketed TriFix Spinal System.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This filing does not describe a machine learning or AI-based device that would require a 'training set.'
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.
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MAR 1 1 2002
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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: |
|---|---|
| DeviceName | 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
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KOI 4090
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| 7.6DeviceDescription | The Endius Spinal Fixation System is a system that is intended to be used forposterior lumbar fusion procedures. The system is manufactured from titaniumwhich complies with ASTM F136. The components, which are included as partof the system, include screws, rods, plates, and accessory connectioncomponents. |
|---|---|
| 7.7DeviceIndicationsandIntendedUse | The Endius Spinal Fixation System is indicated for degenerative disc disease(defined as discogenic back pain with degeneration of the disc confirmed byhistory and radiographic studies). Levels of fixation are the thoracic, lumbar,and sacral spine.The Endius Spinal Fixation System is a pedicle screw system intended toprovide immobilization and stabilization of spinal segments in skeletally maturepatients as an adjunct to fusion in the treatment of the following acute andchronic instabilities or deformities of the thoracic, lumbar, and sacral spine:degenerative spondylolisthesis with objective evidence of neurologicalimpairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failedprevious fusion (pseudarthrosis).The Endius Spinal Fixation System is also indicated for pedicle screw fixationfor severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally maturepatients, when autogenous bone graft is used, when affixed to the posteriorlumbosacral 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 pediclescrews, is indicated for posterior hook and sacral screw fixation from T1 to theilium/sacrum. The non-pedicle screw indications are spondylolisthesis,degenerative disc disease (discogenic back pain with degeneration of the discconfirmed 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
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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 andbox labeling includingall of the necessarywarning statements | Instructions for use and boxlabeling including all of thenecessary warning statements |
| Packaging/Sterilization | Non-sterile, single useonly | Non-sterile, single use only |
| BiomechanicalTest Results | Complies with ASTMF1717 | Complies with ASTM F1717 |
Applicant_
:
Date_
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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.
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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
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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)
§ 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.