IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE

K983667 · Ionics Medical Corp. · MQP · Jul 5, 2000 · Orthopedic

Device Facts

• Record ID: K983667
• Device Name: IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
• Applicant: Ionics Medical Corp.
• Product Code: MQP · Orthopedic
• Decision Date: Jul 5, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be always implanted with adjunctive fixation. To replace a vertebral body for tumor and to replace or restore the height of a vertebral body due to fracture; for example, burst or compression fractures To facilitate anterior decompression of the spinal cord and neural structure To facilitate the reduction of kyphotic deformities

Device Story

Levante Intervertebral Pillar is an expandable spinal prosthesis; designed for thoracolumbar (T1-L5) vertebral body replacement. Device restores vertebral height following tumor resection or fracture (e.g., burst/compression); facilitates anterior decompression of spinal cord/neural structures; aids reduction of kyphotic deformities. Implanted by surgeons in clinical/OR settings; requires mandatory adjunctive fixation. Device provides structural support to replace up to two contiguous vertebral bodies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Expandable intervertebral pillar prosthesis; thoracolumbar application; metallic construction (implied by device type); designed for surgical implantation with adjunctive fixation.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor resection or excision, or vertebral body fracture (e.g., burst or compression). Used to restore height, facilitate anterior decompression of spinal cord/neural tissues, and reduce kyphotic deformities. Limited to replacement of maximum two contiguous vertebral bodies. Must be used with adjunctive fixation.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2000

Mr. M. Laine Mashburn Ionics Medical Corporation 702 13th Street, #108 Miami Beach, Florida 33139

Re: K983667

Trade Name: Levante Intervertebral Pillar Regulatory Class: II Product Code: MQP Dated: April 5, 2000 Received: April 6, 2000

Dear Mr. Mashburn:

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 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). 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 requirements, 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 - Mr. M. Laine Mashburn

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" (21CFR 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 [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Lila Witt
Salia M. Witt, Ph.D., M.D.

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

Enclosure

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#### EXHIBIT B (Amendment)

## INDICATIONS FOR USE (CDRH/ ODE Optional Format published 1/02/96)

510 (k) Number: K983667

Device Name:

Ionics Levante Intervertebral Pillar, Expandable (from Ionics Medical Corporation)

## Indications (as amended June/19/00):

- The Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be always implanted with adjunctive fixation.

- To replace a vertebral body for tumor and to replace or restore the height of a vertebral body due to fracture; for example, burst or compression fractures
- To facilitate anterior decompression of the spinal cord and neural structure
- To facilitate the reduction of kyphotic deformities

# (PLEASE DO NOT WRITE BELOW THIS LINE)

Image /page/2/Figure/12 description: The image shows a table with the text "Concurrence of CDRH, Office of Device Evaluation (ODE)" below it. The table has three columns, but they are all empty. The text is centered below the table. The table is surrounded by a thick black border.

Elin Watt

(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801. 109)

(CDRH/ODE Optional Format 1/02/96)