MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM

K061576 · Quantum Orthopedics, Inc. · MQP · Jul 3, 2006 · Orthopedic

Device Facts

• Record ID: K061576
• Device Name: MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
• Applicant: Quantum Orthopedics, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantum Vertebral Body Replacement System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, 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 (VBR) System; flanged, box-shaped implant with external teeth and screw holes for fixation to bone; prevents implant migration. Used in thoracic/thoracolumbar spine (T1-L5) to replace resected/excised vertebral bodies due to tumor or trauma. Implanted by surgeons during vertebrectomy procedures; interior space packed with allograft or autograft to facilitate fusion. Requires supplemental spinal fixation (e.g., pedicle screw/rod or anterior plate systems). Provides structural support to spinal column; restores stability following vertebral body removal.

Clinical Evidence

Bench testing only. Mechanical testing performed to demonstrate the system is capable of performing in accordance with its intended use.

Technological Characteristics

Materials: Titanium and polyetheretherketone (PEEK). Design: Flanged, box-shaped body with external teeth and screw holes for fixation. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring replacement of collapsed, damaged, or unstable vertebral bodies in the thoracic/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

Submission Summary (Full Text)

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K061576 Quantum Orthopedics, Inc. Special 510(k) – Quantum Vertebral Body Replacement System Page 1 of 2

## 510(k) Summary Quantum Vertebral Body Replacement System

JUL - 3 2006

| Manufacturer Identification<br>Submitted by: | Quantum Orthopedics, Inc.<br>2744 Loker Ave. W., Suite 100<br>Carlsbad, CA 92010<br>760-607-0121 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Jason Blain<br>Chief Technology Officer<br>Quantum Orthopedics, Inc.<br>2744 Loker Ave. W., Suite 100<br>Carlsbad, CA 92010<br>760-607-0121<br>[e-mail] |
| Date Prepared: | June 6, 2006 |
| Device Identification<br>Proprietary Name: | Quantum Vertebral Body Replacement System |
| 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 System is composed of a flanged VBR body with screw holes and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry and teeth on its external surfaces. Screws pass through screw holes and affix to bone to help prevent implant migration. The devices are available in a multitude of sizes and are made from titanium and 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, 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 System is capable of performing in accordance with its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

Quantum Orthopedies. Inc. c.o Mr. Jason Blain. Chief Technology Officer 2744 Loker Ave. W., Suite 100 Carlsbad. CA 92010

Re: K061576

Trade Name: Quantum VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 6, 2006 Received: June 7, 2006

Dear Mr. Blain:

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. Blain

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 not hast 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 lectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 100, 11050. This letter will allow you to begin marketing your device as described in your Scetion 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legal|y marketed predicate device results in a classification for your device and thus, permitts 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 mon ohtain 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/industrv/support/index.html.

Sincerely yours,

Charbang buelirp

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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# Indications for Use

| 510(k) Number: | K061576 |
|----------------|-------------------------------------------|
| Device Name: | Quantum Vertebral Body Replacement System |

### Indications For Use:

The Quantum Vertebral Body Replacement System 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.

Prescription Use X (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)

Sharbare Buchund for MCM
(Division Sign-Off)

Division of Ger and Neurologics

510(k) Number K061576