TRI-FIX SPINAL FIXATION SYSTEM

K011830 · Endius, Inc. · KWP · Jul 23, 2001 · Orthopedic

Device Facts

• Record ID: K011830
• Device Name: TRI-FIX SPINAL FIXATION SYSTEM
• Applicant: Endius, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jul 23, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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-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.

Device Story

Tri-Fix Spinal Fixation System; posterior spinal fixation hardware including screws, rods, plates, and accessory connectors. Used by surgeons in clinical settings for spinal fusion procedures. Provides mechanical immobilization and stabilization of spinal segments. Titanium construction. Output is physical structural support to facilitate bone fusion. Benefits patient by stabilizing unstable spinal segments and correcting deformities.

Clinical Evidence

Bench testing only. Biomechanical testing demonstrated that the stiffness range of the Tri-Fix Spinal System is within the range of the predicate ISOLA Spinal System.

Technological Characteristics

Titanium construction (ASTM F136). Components include screws, rods, plates, and accessory connection components. Non-sterile, single-use device. Mechanical fixation system.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions: degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and severe spondylolisthesis (grades 3-4 at L5-S1). Levels: thoracic, lumbar, sacral spine (T1 to ilium sacrum).

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

• ISOLA Spinal System (DePuy, Acromed, Inc.)

Submission Summary (Full Text)

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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

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# 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.

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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<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 | Stiffness Range=<br>within the range of<br>ISOLA | Stiffness Range=<br>Outside the range of TriFix |

Applicant

Date__________________________________________________________________________________________________________________________________________________________________________

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#### 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.

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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 [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" (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 [phone] or at [phone], 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

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## 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