ISS INTEGRATED SPINE SYSTEM

• K Number: K061524
• Device Name: ISS INTEGRATED SPINE SYSTEM
• Manufacturer: ORTHO DEVELOPMENT CORP.
• Date Cleared: 2006-09-26 ( 116 days)
• Product Code: MNH , KWP , MNI
• Regulation Number: 888.3070
• Type: Traditional
• Panel: Orthopedic
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 o1 Tumors
7. Revision of previously failed fusion surgery
8. Degenerative Disk Discasc
9. Stabilization after Osteotomy

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Ortho Development Corporation for their Integrated Spine System (ISS). It details the device's classification, regulatory information, and indications for use.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria for performance metrics. It's a regulatory clearance document, not a performance study report.

Therefore, I cannot provide the requested information based solely on the provided text.

To answer your questions, I would need a different type of document, such as:

• A clinical study report
• A summary of safety and effectiveness data (often submitted with 510(k)s but not included in this FDA clearance letter)
• A detailed performance testing report

Without such a document, any answers would be speculative and not based on the provided input.

Summary

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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

Regulation Number and Section

N/A