PARAMOUNT VBR SYSTEM

K062759 · Innovative Spinal Technologies, Inc. · MQP · Jan 12, 2007 · Orthopedic

Device Facts

• Record ID: K062759
• Device Name: PARAMOUNT VBR SYSTEM
• Applicant: Innovative Spinal Technologies, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Jan 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

Device Story

Paramount™ VBR is a single-piece vertebral body replacement implant; manufactured from PEEK-Optima®; available in various widths, heights, angles, and lengths to accommodate patient anatomy. Implanted singly or in pairs in the thoracolumbar spine (T1-L5) to replace collapsed, damaged, or unstable vertebral bodies; used to achieve spinal cord/neural tissue decompression and restore vertebral height. May be used with supplemental fixation (e.g., Paramount™ Pedicle Screw System). Implants provided sterile; instruments provided clean/non-sterile for facility steam sterilization. Used by surgeons in clinical/OR settings to provide structural support to the spine.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02. Biocompatibility testing was also performed.

Technological Characteristics

Material: PEEK-Optima®. Form factor: Single-piece implant, various dimensions. Energy source: None (mechanical). Sterilization: Sterile (implants), steam (instruments). Standards: ASTM F2077, ASTM F2267, ASTM F-04.25.02.02.

Indications for Use

Indicated for patients requiring partial vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor, trauma, or fracture to achieve decompression and restore vertebral height.

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.

Predicate Devices

• Spinal Concepts Inc. TRAXIS™ (K033517)
• Pioneer® Vertebral Spacer (K043206)
• SpineVision Spacevision™ Cage (K042930)

Submission Summary (Full Text)

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JAN 1 2 2007

## 510(k) SUMMARY

DATE: November 17, 2006 SUBMITTER: Innovative Spinal Technologies, Inc. 111 Forbes Blvd. Mansfield, MA 02048 Telephone: [phone] Fax: [phone] CONTACT PERSON: Gina Yeh TRADE NAME: Paramount™ Vertebral Body Replacement System FDA CLASSIFICATION/ CODE: 888. 3060. MQP

DEVICE DESCRIPTION: The Paramount™ VBR device is a single piece device that may be implanted singly or in pairs. All devices are made of PEEK-Optima®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The system implants are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.

INTENDED USE: The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

Spinal Concepts Inc. TRAXIS™ (K033517), Pioneer® PREDICATE DEVICES: Vertebral Spacer (K043206), and SpineVision Spacevision™ Cage (K042930).

PERFORMANCE DATA: The mechanical test results based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02 demonstrate that the Paramount™ VBR device can be expected to perform in a manner substantially equivalent to the predicate devices. In addition, biocompatibility of the device was demonstrated.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innovative Spinal Technologies, Inc. % Ms. Gina Yeh Program Manager, Regulatory Affairs 111 Forbes Boulevard Mansfield, Massachusetts 02048

JAN 1 2 2007

Re: K062759

Trade/Device Name: Paramount™ VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 22, 2006 Received: December 26, 2006

Dear Ms. Yeh:

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 misbrandijne 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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, U.A.may publish further announcements concerning your device in the Federal Register.

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.

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Page 2 - Ms. Gina Yeh

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 vours.

Sorban Buckun

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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## Indication for Use Statement

510(k) Number:_ K062759

Device Name: Paramount™ VBR System

Indications:

The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

Prescription Use _ × or (21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubace Buchur

. Restorative. and Neurological Devices

**510(k) Number** Ko63759