TRIPLE-FIX SPINAL FIXATION SYSTEM

K992147 · Advanced Spine Technology, Inc. · MNI · Feb 28, 2000 · Orthopedic

Device Facts

• Record ID: K992147
• Device Name: TRIPLE-FIX SPINAL FIXATION SYSTEM
• Applicant: Advanced Spine Technology, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Feb 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Triple-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 spondylolithesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The posterior Triple-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 Triple-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

Triple-Fix Spinal Fixation System; posterior spinal fixation hardware including screws, rods, plates, and connectors. Used by surgeons in spinal fusion procedures to provide immobilization and stabilization of thoracic, lumbar, and sacral segments. Manufactured from titanium (ASTM F136) or stainless steel. System components are implanted to treat acute/chronic instabilities or deformities; pedicle screws intended for removal after solid fusion in severe spondylolisthesis cases. Device provides mechanical support to facilitate bone fusion; clinical benefit derived from stabilization of spinal segments.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1717 to demonstrate substantial equivalence to predicate systems.

Technological Characteristics

Components: screws, rods, plates, connectors. Materials: Titanium (ASTM F136) or stainless steel. Non-sterile, single-use. Mechanical fixation principle. No software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as adjunct to fusion. Treats thoracic, lumbar, and sacral spine instabilities/deformities including degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and degenerative disc disease. Pedicle screw fixation indicated for severe spondylolisthesis (grades 3-4) at L5-S1. Non-pedicle screw fixation (hooks, wires, sacral screws) indicated from T1 to ilium sacrum.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• Isola Spinal System (Acromed)
• Mirage Spinal System (Alphatec, Inc.)

Submission Summary (Full Text)

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# K992147 FEB 2 8 2000

# 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 | Advanced Spine Technology, Inc. |
|-----------|----------------------------------------------------|
| Submitter | 3645 Grand Avenue, Suite 304<br>Oakland, CA. 96410 |

| 7.3 | Susan Finneran |
|---------|---------------------------------------------------------------------------|
| Company | QA/RA Manager (Endius, Inc.) |
| Contact | 508-643-0983<br>Acting as a consultant to Advanced Spine Technology, Inc. |

| 7.4 | Proprietary Name:<br>Triple-Fix Spinal Fixation System |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Common Name:<br>Pedicle Screw System , Non-pedicle spinal fixation system<br>Classification Name:<br>Spinal Pedicle Screw (MNI),Spinal Interlaminal fixation orthosis (KWP),<br>Spondylolithesis Spinal Fixation Device System (MNH) |

| 7.5<br>Predicate | Isola Spinal System (Acromed, Cleveland, OH.) |
|--------------------------------|---------------------------------------------------------|
| Legally<br>Marketed<br>Devices | Mirage Spinal System (Alphatec, Inc., Palm Desert, CA.) |

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#### The Advanced Spine Technology Triple-Fix Spinal System is a system that is 7.6 intended to be used for posterior lumbar fusion procedures. The system is Device manufactured from titanium which complies with ASTM F136. The Description 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 Triple-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 spondylolithesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis).

The posterior Triple-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 Triple-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 The Triple-Fix Spinal System is substantially equivalent to the Isola Spinal Substantial System ( Acromed, Cleveland, OH.) and the Mirage Spinal System (Sofamor Equivalence Danek, Memphis, TN.) Following is a table which describes the features of the new and the predicate systems which indicate substantial equivalence. Testing was also completed as per ASTM F1717 in order to demonstrate equivalence. The results of testing are included in appendix 1 of the submission.

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Kgg 2147

pl's 320 3

# 7.9 Table of Substantial Equivalence

| Device Name | The Triple-Fix Spinal System | Mirage Spinal System | Isola Spinal System |
|-----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Product<br>Components | Screws, Connectors,<br>Plates, Rods, and<br>offset Connectors. | Hooks, screws, rods,<br>and offset connectors. | Hooks, Screws,<br>Connectors, Plates,<br>Rods, and offset<br>connectors. |
| Indications for Use | See above | Identical | Identical |
| Materials | Stainless Steel or<br>Titanium | Stainless Steel or<br>Titanium | Stainless Steel or<br>Titanium |
| Product Labeling | Instructions for use<br>and box labeling<br>including all of the<br>necessary warning<br>statements | Instructions for use<br>and box labeling<br>including all of the<br>necessary warning<br>statements | Instructions for use<br>and box labeling<br>including all of the<br>necessary warning<br>statements |
| Packaging/<br>Sterilization | Non-sterile, single<br>use only | Non-sterile, single use<br>only | Non-sterile, single use<br>only |

Applicant

:

Date 2/25/00

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2000

Ms. Susan Finneran QA/RA Manager Representing Advance Spine Technologies, Incorporated Endius, Incorporated 23 West Bacon Street Plainville, Massachusetts 02762

Re: K992147

Trade Name: Triple-Fix Spinal Fixation System Regulatory Class: II Product Code: MNI, MNH and KWP Dated: November 29, 1999 Received: November 30, 1999

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 control provisions of the Act. The general control 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,

Humillación

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): K992147

## Device Namc: Triple-Fix Spinal Fixation System (Stainless Steel and Titanium)

### Indications for Use:

The Triple-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 spondylolithesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The posterior Triple-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 Triple-Fix System, when not used with pedicle screws is indicated for hook, wire, and for 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), turnor, 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)

(Posted July 1, 1998)

Humid Vagn

(Optional Format 3-10-98)

(Division Sign-Off) Division of General Restorative Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)