MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT

K062004 · Quantum Orthopedics, Inc. · MQP · Aug 15, 2006 · Orthopedic

Device Facts

• Record ID: K062004
• Device Name: MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT
• Applicant: Quantum Orthopedics, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Aug 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

Device Story

Quantum Vertebral Body Replacement is a box-shaped spinal implant; features exterior teeth to prevent migration; available in multiple sizes to accommodate patient anatomy. Constructed from titanium or PEEK. Implanted during partial or total vertebrectomy procedures in thoracic/thoracolumbar spine (T1-L5). Requires use with supplemental spinal fixation systems (e.g., posterior pedicle screw/rod, anterior plate/screw systems). Interior space allows packing with allograft or autograft. Used by surgeons to restore spinal stability following tumor resection or traumatic fracture.

Clinical Evidence

Bench testing only. Mechanical testing indicates the device is capable of performing in accordance with its intended use.

Technological Characteristics

Box-shaped vertebral body replacement; materials: titanium or PEEK; exterior surface features teeth for fixation; available in multiple sizes; intended for use with supplemental spinal fixation systems; interior cavity for bone graft packing.

Indications for Use

Indicated for patients requiring replacement of collapsed, damaged, or unstable vertebral bodies in the thoracic and/or thoracolumbar spine (T1-L5) following partial or total vertebrectomy due to tumor or trauma (fracture). Must be used with cleared supplemental spinal fixation systems.

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

• Quantum Vertebral Body Replacement (K062004)

Submission Summary (Full Text)

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Quantum Orthopedics, Inc. Special 510(k) -- Quantum Vertebral Body Replacement

# 510(k) Summary Quantum Vertebral Body Replacement

510(k) Number K O 6 2 00 4

AUG 1 5 2006

| Manufacturer Identification | |
|-----------------------------|------------------------------------|
| Submitted by: | Quantum Orthopedics, Inc. |
| | 2744 Loker Ave. W., Suite 100 |
| | Carlsbad, CA 92010 |
| | 760-607-0121 |
| Contact Information: | Kerri DiMartino |
| | Regulatory Affairs Specialist |
| | Quantum Orthopedics, Inc. |
| | 2744 Loker Ave. W., Suite 100 |
| | Carlsbad, CA 92010 |
| | 760-607-0121 |
| | [e-mail] |
| Date Prepared: | July 14, 2006 |
| Device Indentification | |
| Proprietary Name: | Quantum Vertebral Body Replacement |
| Common Name: | Vertebral Body Replacement |
| Classification Name: | Spinal Vertebral Body Replacement |

#### Predicate Devices

The subject device is substantially equivalent to the previously cleared Quantum Vertebral Body Replacement.

#### Device Description

The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).

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# Intended Use of the Device

The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

## Performance Data

Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2006

Quantum Orthopedics, Inc. c/o Ms. Kerri DiMartino, Regulatory Affairs Specialist 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010

Re: K062004

Trade Name: Quantum VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 14, 2006 Received: July 17, 2006

Dear Ms. DiMartino:

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 r ou mayy arovisions 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 - Ms. Kerri DiMartino

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,

Яавадзиенит

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

Enclosure

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# Indications for Use

510(k) Number (if known): K 94200 4

Device Name: Quantum Vertebral Body Replacement

## Indications For Use:

The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral or resected or excised (i.e., partial or total vertebrectorny procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle surew and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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)

~~Division Sign-Off~~
Dubuque Briefing for MXM

Division of General, Rest crative, and Neurological Devices

510(k) Number_

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