When used as a pedicle screw fixation system (MNH) The Contour™ Spinal System is PC PC indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 indicated for the treating to ture patients receiving fusion by autogenous bone graft having ventooral joint in skelonymbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion mass.

Use of a hook, rod, and ileo-sacral screw fixation system (KWP) T1-S1, the Lumbar Hook Sacral Screw Construct of the Contour " Spinal System, will assist in arthrodesis or fusion of the thoracic, lumbar and lumbosacral spine. The indications for use are:

Spondylolisthesis; .
Fracture:
Spinal Stenosis;
Deformities (scoliosis, kyphosis, lordosis); .
Pseudarthrosis ●
Tumor ●
Revision of previously failed fusion surgery .

The hooks are to be used for fixation to include the first thoracic vertebra down to the sacrum. The pedicle screws are used for sacral fixation only.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the Contour Spinal System, dated October 14, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria, device performance, studies conducted, sample sizes, ground truth establishment, or expert qualifications. The clearance letter primarily confirms that the device can be marketed based on its substantial equivalence to existing devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory clearance and not a study report.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or ribbons, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Ms. Carol Freasier Manager, Regulatory Affairs Quality Assurance Ortho Development Corporation 106 West Business Park Drive Draper, Utah 84020

K990986 Re:

Trade Name: Contour Spinal System® Regulatory Class: II Product Code: KWP and MNH Dated: July 26, 1999 Received: July 28, 1999

Dear Ms. Freasier:

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 enclosures) 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

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Page 2 - Ms. Carol Freasier

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.

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

S. Gale M. Witmer, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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K990986 510(k) Number (ff known):

Device Name: Contour™ Spinal System

Indications for Use

Spondylolisthesis; .
Fracture:
Spinal Stenosis;
Deformities (scoliosis, kyphosis, lordosis); .
Pseudarthrosis ●
Tumor ●
Revision of previously failed fusion surgery .

The hooks are to be used for fixation to include the first thoracic vertebra down to the sacrum. The pedicle screws are used for sacral fixation only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

. O'Dell

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

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
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.(b)
Classification. Class II.