ISS INTEGRATED SPINE SYSTEM

K061524 · Ortho Development Corp. · MNH · Sep 26, 2006 · Orthopedic

Device Facts

• Record ID: K061524
• Device Name: ISS INTEGRATED SPINE SYSTEM
• Applicant: Ortho Development Corp.
• Product Code: MNH · Orthopedic
• Decision Date: Sep 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Integrated Spine System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous hone graff and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion mass. Use of a rod and ileo-sacral screw fixation system, T1-S1, the lumbar screws and rods will assist in arthrodesis or fusion of the lumbar spine. The indications for use are: 1. Spondylolisthesis 2. Spinal Fractures 3. Spinal Stenosis 4. Deformities (Idiopathic Scoliosis, Adult Kyphosis, Lordosis) 5. Pseudarthrosis of previous fusion 6. Instability caused by Trauma or Tumors 7. Revision of previously failed fusion surgery 8. Degenerative Disk Disease 9. Stabilization after Osteotomy

Device Story

Integrated Spine System (ISS) is a pedicle screw fixation system; provides stabilization for spinal arthrodesis/fusion. Components include rods and ileo-sacral screws; implanted in lumbar and sacral spine (T1-S1). Used by surgeons in clinical settings to treat spinal pathologies including deformities, fractures, and degenerative conditions. System provides mechanical support to assist bone graft fusion; implants intended for removal after solid fusion mass attainment. Benefits include spinal stabilization and correction of instability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pedicle screw fixation system; includes rods and ileo-sacral screws. Designed for T1-S1 spinal attachment. Mechanical fixation device.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion for severe spondylolisthesis (Grades 3-4 at L5-S1), spinal fractures, stenosis, deformities (scoliosis, kyphosis, lordosis), pseudarthrosis, instability from trauma/tumors, failed fusion revision, degenerative disk disease, or post-osteotomy stabilization.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 26 2006

Ortho Development Corporation c/o Mr. William J. Griffin 12187 South Business Park Drive Draper, Utah 84020

-Re: K061524

Trade Name: ISSTM Integrated Spine System Regulation Number: 21 CFR 888.3070(b)(1) Regulation Name: Pedicle Screw Fixation System Regulatory Class: II Product Code: MNH, MNI, KWP Dated: August 16, 2006 Received: August 17, 2006

Dear Mr. Griffin:

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.

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# Page 2 - Mr. William J. Griffin

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark M. Milburn

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ortho Development - 510(k) Integrated Spine System (ISS) Page 1 of 1

## Indications for Use

#### 510(k) Number (if known): K061524

Device Name:

Integrated Spine System (ISSTM)

### Indications for Use

The Integrated Spine System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous hone graff and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion mass.

Use of a rod and ileo-sacral screw fixation system, T1-S1, the lumbar screws and rods will assist in arthrodesis or fusion of the lumbar spine. The indications for use are:

- Spondylolisthesis 1.
- 2. Spinal Fractures
- Spinal Stenosis 3.
- 4. Deformities (Idiopathic Scoliosis, Adult Kyphosis, Lordosis)
- Pseudarthrosis of previous fusion 5.
- Instability caused by Trauma o1 Tumors (.
- 7. Revision of previously failed fusion surgery
- 8. Degenerative Disk Discasc
- ್ರ. Stabilization after Osteotomy

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bruckner

ion of General. Restorative. and Neurological De

510(k) Number K061524