ENDIUS SPINAL FIXATION SYSTEM

K014090 · Endius, Inc. · KWP · Mar 11, 2002 · Orthopedic

Device Facts

• Record ID: K014090
• Device Name: ENDIUS SPINAL FIXATION SYSTEM
• Applicant: Endius, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Mar 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Endius Spinal Fixation System; orthopedic implant system for posterior lumbar fusion. Components include titanium screws, rods, plates, and accessory connectors. Used by surgeons in clinical settings to provide spinal segment immobilization and stabilization. Implanted during surgical procedures to treat spinal instabilities or deformities. Benefits patients by facilitating fusion and correcting spinal alignment. Non-sterile, single-use device.

Clinical Evidence

Bench testing only. Biomechanical testing performed in compliance with ASTM F1717.

Technological Characteristics

Materials: Titanium (ASTM F136). Components: Screws, rods, plates, accessory connectors. Biomechanical compliance: ASTM F1717. Sterilization: Non-sterile, single-use.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats degenerative disc disease, degenerative spondylolisthesis (including severe Grades 3-4 at L5-S1), fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis. Levels: thoracic, lumbar, sacral spine.

Regulatory Classification

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.

Predicate Devices

• TriFix Spinal System (K014090)

Submission Summary (Full Text)

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MAR 1 1 2002

K014090

page 1 of 3

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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: |
|----------------|---------------------------------------------------------------------------------------------------------------------------------|
| Device<br>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),<br>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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| 7.6<br>Device<br>Description | The Endius Spinal Fixation System is a system that is intended to be used for<br>posterior lumbar fusion procedures. The system is manufactured from titanium<br>which complies with ASTM F136. The components, which are included as part<br>of the system, include screws, rods, plates, and accessory connection<br>components. |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.7<br>Device<br>Indications<br>and<br>Intended<br>Use | The Endius Spinal Fixation System is indicated for degenerative disc disease<br>(defined as discogenic back pain with degeneration of the disc confirmed by<br>history and radiographic studies). Levels of fixation are the thoracic, lumbar,<br>and sacral spine.<br>The Endius Spinal Fixation System is a pedicle screw system intended to<br>provide immobilization and stabilization of spinal segments in skeletally mature<br>patients as an adjunct to fusion in the treatment of the following acute and<br>chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:<br>degenerative spondylolisthesis with objective evidence of neurological<br>impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed<br>previous fusion (pseudarthrosis).<br>The Endius Spinal Fixation System is also indicated for pedicle screw fixation<br>for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature<br>patients, when autogenous bone graft is used, when affixed to the posterior<br>lumbosacral spine, and intended to be removed after solid fusion is obtained.<br>Levels of fixation are L3-S1.<br>In addition, the Endius Spinal Fixation System, when not used with pedicle<br>screws, is indicated for posterior hook and sacral screw fixation from T1 to the<br>ilium/sacrum. The non-pedicle screw indications are spondylolisthesis,<br>degenerative disc disease (discogenic back pain with degeneration of the disc<br>confirmed by history and radiographic studies), deformities (scoliosis, lordosis,<br>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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K014090

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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 and<br>box labeling including<br>all of the necessary<br>warning statements | Instructions for use and box<br>labeling including all of the<br>necessary warning statements |
| Packaging/<br>Sterilization | Non-sterile, single use<br>only | Non-sterile, single use only |
| Biomechanical<br>Test Results | Complies with ASTM<br>F1717 | 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted July 1, 1998)

(Optional Format 3-10-98)