QUANTUM VERTEBRAL BODY REPLACEMENT

K050449 · Quantum Orthopedics, Inc. · MQP · Jul 7, 2005 · Orthopedic

Device Facts

• Record ID: K050449
• Device Name: QUANTUM VERTEBRAL BODY REPLACEMENT
• Applicant: Quantum Orthopedics, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Jul 7, 2005
• Decision: SESE
• Submission Type: Traditional
• 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, 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

Box-shaped vertebral body replacement device; features exterior teeth to prevent migration; available in multiple sizes. Fabricated from titanium or PEEK. Implanted during spinal surgery (partial or total vertebrectomy) to replace collapsed/unstable vertebral bodies in thoracic/thoracolumbar spine (T1-L5). Requires use with cleared supplemental spinal fixation systems (e.g., pedicle screws, rods, plates). Interior cavity designed for packing with autograft or allograft bone material. Used by surgeons in clinical/OR settings to restore spinal stability.

Clinical Evidence

Bench testing only.

Technological Characteristics

Box-shaped vertebral body spacer; materials: titanium or polyetheretherketone (PEEK); features surface teeth for fixation; available in multiple sizes; intended for use with supplemental spinal fixation systems; non-active, mechanical implant.

Indications for Use

Indicated for patients requiring replacement of a collapsed or unstable vertebral body in the thoracic or thoracolumbar spine (T1-L5) following partial or total vertebrectomy due to tumor or trauma (fracture). Must be used with supplemental spinal 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.

Predicate Devices

• Sustain Radiolucent Spacer (K040284)
• Cadence (K033517)
• Traxis (K033517)
• PEEK Tetris (K031757)
• PEEK Tetris (K041888)
• STALIF TT (K041617)
• SynMesh (K003275)

Submission Summary (Full Text)

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JUL 7 - 2005

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Premarket Notification - Quantum Vertebral Body Replacement

# 510(k) Summary Quantum Vertebral Body Replacement

## 510(k) Number K050449

| Manufacturer Identification<br>Submitted by: | Quantum Orthopedics, Inc.<br>2744 Loker Ave. W., Suite 100<br>Carlsbad, CA 92008<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 92008<br>760-607-0121<br>[e-mail] |
| Date Prepared: | May 13, 2005 |
| Device Indentification<br>Proprietary Name: | Quantum Vertebral Body Replacement |
| Common Name: | Vertebral Body Replacement |
| Classification Name: | Spinal 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).

#### 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

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rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

### Substantial Equivalence

The Quantum Vertebral Body Replacement was shown to be substantially equivalent to Sustain Radiolucent Spacer (Globus Medical, Inc., K040284), Cadence™ and Traxis™ (Spinal Concepts, K033517), PEEK Tetris™ (Signus Medical LLC, K031757 and K041888), STALIFTM TT (Surgicraft, K041617), and SynMesh (Synthes, K003275).

## 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 7 - 2005

Mr. Jason Blain Chief Technology Officer Quantum Orthopedics 2744 Loker Avenue West. Suite 100 Carlsbad, California 92008

Re: K050449

Trade/Device Name: Quantum Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: May 13, 2005 Received: May 16, 2005

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. Iisting 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.

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 - Mr. Jason Blain

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,

S. Hugh Rudder, Ph.D.

Miriam Provost, Ph.D. Acting 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):

Quantum Vertebral Body Replacement Device Name:

# 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 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 × (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)

Hupt Plurdu

(Division Division of General, Restorative and Neurological Devices

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510(k) Number K050449